Discovery Research Collaboratives

This study seeks to determine the safest and most effective approach to sepsis intervention using the Surviving Sepsis Campaign guidelines. The study is funded by a grant from the National Heart, Lung, and Blood Institute.
 
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This program is a collaboration between the Society of Critical Care Medicine (SCCM) and the CURE Drug Repurposing Collaboratory (CDRC) to extend SCCM’s VIRUS Registry work beyond its current scope. The goal is to crowdsource the global medical community for their experience in using repurposed drugs to treat infectious diseases that have no adequate approved therapies, such as COVID-19. This information may help identify promising treatments that can be investigated further. It may also help identify ineffective treatments. A package of tools called the edge tool will be tested; its purpose is to help healthcare institutions participate in CURE-ID with minimal effort. The investigators plan to expand beyond COVID-19 to sepsis and meningitis. The project’s focus is to create the data infrastructure locally for future research studies and embedded clinical trials. As of 12/11/23, there are 6 sites that have implemented the edge tool and transferred data (with review & clean up) totaling just under 70,000 patients.
 
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This study seeks to establish the effectiveness of a combination of an inhaled corticosteroid and a beta-agonist compared to placebo for the prevention of acute respiratory failure in hospitalized patients with pneumonia and hypoxemia.

This was a multicenter consortium funded by the National Foundation for the Centers for Disease Control and Prevention, with the goal of providing the infrastructure to rapidly collect prospective data on clinical risks and outcomes, hospital-level stress, and biologic specimens to aid in the rapid development of diagnostic and treatment approaches.
 
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This registry contains data on current hospital care patterns to allow evaluations of safety and observational effectiveness of COVID-19 practices and determine variations in practice across hospitals.

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Structured Team-based OPtimal critical care for Trauma victims (STOP-Trauma) comprises a network of Ukrainian intensivists and international experts in wartime trauma experience who use their knowledge to support one another in treating Ukrainian civilians impacted by war.
 
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The APPLE research project aims to enhance outcomes for critically ill children with acute pulmonary failure requiring invasive mechanical ventilation. This will be achieved through the implementation of Structured, Tailored Feedforward with Guided Toolkit Application (STF-GTA) coupled with standard enhanced usual care. The study will assess key clinical effectiveness measures, including the duration of invasive mechanical ventilation, pediatric intensive care unit length of stay, incidence of delirium, and changes in functional status associated with critical illness. Implementation goals involve improving the proportion of sedation and ventilation assessments linked to weaning and reducing the time to initial extubation readiness testing. The study will span 20 academic and community hospitals, enrolling 4000 children over four years. Each site will establish an APPLE research team consisting of various stakeholders. Research participation entails minimal risk. Parental consent will be sought after initial enrollment. Data will be efficiently collected from electronic health records using specialized software tools. The analysis will employ a negative binomial model adjusted for hospital type, with due consideration of model assumptions.

The COVID-19 pandemic dramatically changed all aspects of the intensive care unit (ICU), including treatment strategies for patients with acute respiratory distress syndrome (ARDS), ICU structure and policies, and the implementation of evidence-based and supportive care (e.g., ICU Liberation Bundle, nutrition therapy, ICU diaries, and physical restraints).
 
Data on epidemiology, ARDS treatment, and the implementation of evidence-based and supportive ICU care are lacking in the post-COVID-19 era. To address this lack, the study investigators are inviting investigators with a strong passion for research to participate in this large-scale, international, multicenter observational study that focuses on the outcomes of ICU patients with ARDS, its association with treatment, and the implementation of evidence-based ICU care. All ICUs, including adult, pediatric, and mixed ICUs, are eligible to participate in this study.
 
Study aims are to investigate:

• Epidemiology of ARDS
• Current treatment strategies for ICU patients with ARDS
• Implementation of evidence-based ICU care (e.g., ICU Liberation Bundle, nutrition therapy, ICU diary, speech and swallowing training)
• ARDS-related post-intensive care syndrome: quality of life; employment status; physical, cognitive, and psychiatric function three months after hospital discharge

Inclusion criteria:

• Patients on invasive or noninvasive ventilation within 24 hours of ICU admission
• Patients expected to be on invasive and/or noninvasive ventilation for more than 48 hours
• Patients who meet the diagnosis of ARDS within 24 hours of ICU admission

Exclusion criteria:

• Patients younger than 16 years
• Patients with terminal conditions at the time of ICU admission
• Patients who have been admitted to the ICU with a terminal care policy or who are expected to be admitted to the ICU with a terminal care policy within 24 hours of ICU admission

Patients who have expressed their refusal to have their clinical data used in research

Hyperoxia, defined as fraction of inspired oxygen (Fio₂) greater than 0.5, can be injurious, augments ventilator-associated lung injury, and is associated with higher mortality. Liberal oxygenation practices are also associated with increased mortality in subsets of critically ill patients with post-cardiac arrest, stroke, and traumatic brain injury. Fio₂ is titrated via oxygen saturation (Spo₂); however, there is often a delay in reducing Fio₂ despite adequate Spo₂. Ventilator weaning and liberation may be delayed with inadequate titration. Hyperoxia prevails in most intensive care unit (ICU) settings due to poor awareness of the adverse effects of even mild hyperoxia and the fear that even mild or short duration of hypoxia could be life-threatening.
 
Therefore, there is a critical need to institute measures to improve the practice of Fio₂ titration in a conservative range to maintain optimal oxygen saturation. The plan is to conduct a step-wedge, clustered, randomized implementation by sequential adoption every three months in participating ICUs with concurrent controls available until all sites adopt the protocol.
 
Study aims are to:

• Reduce the duration of hyperoxia in mechanically ventilated critically ill patients
• Demonstrate improved ICU outcomes of increased ventilator-free days and shorter ICU length of stay
• Determine the burden of electronic alerts and learning effects of the alerting process on clinicians

This study will use data form electronic health records and global registries to aggregate and analyze existing drugs that could be repurposed for critical illnesses, such as sepsis and acute kidney injury. This study will create a valuable infrastructure for collecting real-world data on critical care drug repurposing with the hope of leveraging this infrastructure beyond COVID-19. Study objectives are to establish a disease-agnostic, real-world data repository to support drug repurposing in critical care; facilitate the dissemination of the Observational Health Data Sciences and Informatics (OHDSI)/Perseus tool stack for data harmonization; curate large, high-quality, de-identified datasets on diseases and conditions of high unmet clinical need; and promote near-real-time, high-quality, observational research. SCCM will be the data coordinating center for this study.

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Jonathan Sevransky, MD, MHS
 
Sepsis is a clinical syndrome characterized by life-threatening organ dysfunction caused by a dysregulated host response to infection. The treatment of sepsis currently consists of expedient supportive care and control of infection. Recently, a combination of inexpensive medications has been asserted to effectively combat the dysregulated metabolism that accompanies sepsis. These medications include vitamin C, thiamine (vitamin B1), and hydrocortisone. The assertion is based on the before-and-after data reported by a single hospital. The trial received widespread public interest. Response has been mixed, with some clinicians suggesting that the results are too good to be true and others asking whether the combination of medications should be given to all sepsis patients. The most general opinion reflects clinical equipoise: genuine uncertainty among the expert medical community over whether the medication combination treatment will be beneficial, with reciprocal uncertainty as to whether the medication combination will be wasteful or even harmful.
 
We propose to evaluate this potential treatment in a randomized placebo-controlled, multicenter trial. This trial will require 40-60 sites and will have as primary outcome measures the number of days of vasopressor- and ventilator-free days.

This proposal aims to address the ambiguity in vasopressor management for patients with septic shock, focusing on determining the optimal norepinephrine dose when initiating secondary vasopressors. Utilizing a learning health system framework, the study will employ causal inference and comparative effectiveness approaches on electronic medical records data, incorporating clinician priorities through deliberation methods. The research also involves econometrics and semistructured interviews to pilot a pragmatic implementation-effectiveness clinical trial for secondary vasopressor initiation at a data-informed norepinephrine threshold. The comprehensive training plan of Nicholas Bosch, MD, aligns with the Agency for Healthcare Research and Quality core competencies, intending to contribute clinically actionable insights and fill critical knowledge gaps identified by SCCM and the Surviving Sepsis Campaign. The results will guide future multicenter pragmatic clinical trials and inform evidence-based practices in septic shock management.

This study highlights hidden hypoxemia (HH) disparities in patients of color caused by pulse oximetry measurement biases, emphasizing the critical need for accurate monitoring. Current challenges in addressing these disparities, especially for skin pigmentation, demand extensive development and testing of improved hardware. The study proposes a machine learning clinical decision support system (CDSS) leveraging electronic health record (EHR) data to continuously monitor and predict HH risk and reduce HH burden. The study has three aims: assessing the impact of arterial blood gas ordering practices, developing and validating an EHR-based CDSS, and quantifying the clinical impact of HH. Anticipated outcomes include identifying high-benefit patients for CDSS interventions and developing a temporally validated continuous monitor for HH, contributing to improved pulse oximetry equity.

Mechanical circulatory support (MCS) hemodynamically supports patients with refractory cardiogenic shock to preserve end-organ perfusion, especially in the brain, allowing time for native cardiac function to recover or for the patient to receive a definitive intervention. Continuous hemodynamic and cardiac monitoring to prevent end-organ hypoperfusion is considered standard of care in MCS, but a direct assessment of cerebral blood flow (CBF) is not part of current clinical paradigms. Despite its obvious benefit, MCS carries a 15% to 18% rate of neurologic complications related to ischemic stroke, hemorrhagic stroke, and intracerebral hemorrhage, although studies have highlighted that neurologic injury may be clinically undetected in 23% to 50% of cases. Many of these can be minimized by neuromonitoring of serial CBF, cerebral autoregulation (CA), or emboli monitoring.
 
The EuroELSO Working Group on Neurologic Monitoring and Outcome has highlighted the need for continuous cerebral perfusion monitoring, which should be performed as a noninvasive modality in this high-risk population. Transcranial Doppler (TCD) is a noninvasive, portable, relatively inexpensive, and radiation-free diagnostic tool that can continuously measure CBF, CA, and embolic phenomena in critically ill patients. There is a dire need for a systematic investigation to establish normative values for TCD-derived CBF parameters adjusted to MCS device settings, the degree of pulsatility, and the degree of support in this population throughout the course of MCS.
 
This multicenter study aims to describe the relationship between all TCD-derived CBF and CA parameters and various MCS settings (type of device, degree of support, pulsatility, native cardiac output, vasopressor/inotrope use), adjusted for age, gender, race, comorbidities, and extracranial carotid values. The overarching goal is to evaluate the use of TCD-based CBF parameters as a responsive biomarker for titrating MCS parameters and provide patient-centric targets to minimize adverse neurologic events.

This trial addresses the challenge of mechanical ventilation-induced lung injury in patients with respiratory failure by exploring a novel approach focused on minimizing inflation pressures rather than volumes. The trial aims to evaluate the effectiveness of this pressure-limiting strategy across multiple intensive care units in Canada, the United States, Ireland, and Saudi Arabia. Patients will be randomly assigned to either the conventional method of avoiding high inflation volumes or the new approach of avoiding high inflation pressures. The trial seeks to determine whether the pressure-limiting approach enhances patient outcomes, including increased survival chances and accelerated recovery from lung failure.

Bellal Joseph, MD, FACS

Severe traumatic brain injury (TBI) is defined by a Glasgow Coma Scale (GCS) score of less than or equal to 8. This sets a host-adaptive neuroendocrine, immune-metabolic, and inflammatory response that is integrated by an increased sympathetic drive and exaggerated catecholamine surge. This unopposed sympathetic drive triggers a secondary brain insult that occurs hours to days after the primary TBI and manifests as systemic and intracranial hypertension, abnormal heart rate variability, agitation, cerebral edema, and cerebral hypoperfusion to collectively cause the poor neuropsychological outcome. Opposing the sympathetic drive through neutralization of the catecholamine actions in TBI is therefore a viable option for neuroprotection against a secondary brain insult. However, there is no clinical evidence from a prospective randomized trial demonstrating the safety and effectiveness of opposing the sympathetic drive after TBI.
 
Methods/design: OSD-3 is a 2-arm, single-blinded, block-randomized, controlled phase III multicenter trial of the efficacy of early opposing of the sympathetic drive as a neuroprotection strategy in TBI patients with a GCS score of less than or equal to 8. One-half of the qualified patients will be enrolled via exception from informed consent or proxy consent and block-randomized to the opposed sympathetic drive experimental arm. This arm will receive IV propranolol every 6 hours at an adjustable dose to achieve a targeted heart rate of less than 100 beats/min. Propranolol will be held for hypotension (systolic blood pressure < 100 mm Hg) or bradycardia (heart rate < 60 beats/min). The maximum daily dose for the treatment of hypertension of 640 mg will not be exceeded in this study. Patients randomized to the unopposed sympathetic drive control arm will receive the standard-of-care treatment and will not receive propranolol or other β-adrenoceptor antagonist or α-2-agonist. If a patient randomized to the unopposed sympathetic drive arm develops hypertension and increased heart rate, this patient will be treated according to the standard of care by the patient’s trauma team. End-point measurements include plasma catecholamine and metabolites levels, serum levels of neuronal injury-specific biomarkers, heart rate variability, arrhythmia occurrence, infection rate, medication use, agitation measures, coma- and ventilator-free days, intensive care unit (ICU) and hospital lengths of stay, and mortality. Neuropsychological outcomes in the domains of reasoning, concentration, problem-solving, and memory, together with the Glasgow Outcome Scale - Extended (GOS-E) will be performed at hospital discharge and at 3 and 12 months after the injury.
 
The specific aims are to demonstrate that early administration of propranolol after severe TBI:

• Decreases the plasma levels of catecholamine (epinephrine, norepinephrine, and dopamine) and their breakdown products (vanillylmandelic acid, metanephrine, and normetanephrine) measured at day 7
• Decreases serum levels of neuronal injury-specific biomarkers (S100-B, neuron-specific enolase, myelin basic protein, ubiquitin C-terminal hydrolase, tau protein, and glial fibrillary acidic protein) measured at day 7
• Decreases heart rate variability, agitation, arrhythmia, and infection as assessed daily
• Decreases ventilator days, ICU and hospital lengths of stay, and in-hospital mortality as assessed daily
• Improves neuropsychological outcome in the domains of reasoning, concentration, problem-solving, and memory as measured at hospital discharge and at 3 and 12 months after injury
• Improves neurologic outcome as measured by GOS-E at 3 and 12 months after injury

This proposal addresses the global impact of the COVID-19 pandemic on critically ill patients’ well-being in intensive care units (ICUs). With extended periods of isolation and communication challenges, patients face dehumanization, impacting trust and relationships. The proposal introduces a simple yet powerful tool, the Get To Know Me Board, aimed at restoring dignity and humanizing the ICU environment. Using implementation science methods and leveraging a collaborative effort with SCCM, the proposal seeks to implement and rigorously evaluate the effectiveness of this tool in fostering a more compassionate and personalized approach to care for patients, families, and clinicians.

This multidisciplinary project aims to address knowledge gaps in the implementation and effectiveness of telecritical care (TCC) as a care delivery model in the United States. Recognizing the lack of comprehensive data on individual hospitals’ TCC implementation status and program attributes, the study will aggregate information from multiple sources, including the American Hospital Association’s annual survey databases and telemedicine infrastructure vendors, to create a prospective TCC database. Leveraging online, social media-powered crowdsourcing methods, the project seeks to enhance the database’s completeness and accuracy. This initiative is a crucial step toward policy-relevant research, allowing for evaluation of TCC implementation trends, identification of barriers, and comparison of TCC program performances and models.

This is a multicenter quality project to evaluate Molecular Adsorbent Recirculating System (MARS) therapy. The purpose of this study is to describe how MARS affects patients with liver failure who had or will have MARS therapy, including demographics (gender, age, diagnoses, histories, severity of illness) and outcomes (mortality, morbidity, length of hospitalization, complications, changes in mental status, changes in laboratory findings, receipt of liver transplant). The current use of MARS therapy is limited. This study will add to the current body of research regarding the use of MARS in the U.S. population and will report outcomes for patients with all types of liver failure. This project is currently in the phase of building a case report form based on feedback from a group of subject matter experts.

Nonconvulsive seizures detected by continuous electroencephalography (cEEG) occur in about 30% of patients in coma. cEEG is also indicated for aiding in management and prognosis of critically ill patients with brain injury. Guidelines recommend the use of cEEG monitoring in this population to better aid in their management, yet implementation remains challenging.
 
This research proposal consists of an observational study of the use of cEEG for the evaluation and treatment of patients in coma in intensive care units (ICUs) across the United States. The goal is to assess for current practice, quality, barriers to implementation and opportunities for improvement in the use of cEEG for evaluation and treatment of patients in coma.
 
This is a cross-sectional point prevalence observational detailed study of users, equipment, readers, patient categories, and EEG duration in both specialty and general ICUs. One hundred institutions will be recruited through an outreach effort via the Neurocritical Care Research Network (NCRN) and the Critical Care Research Network (CCR-Net). With the endorsement of the NCRN, participation of its 47 institutional members is anticipated. We expect to enroll additional institutions, both academic and nonacademic, via the CCR-Net.
 
Through MECIP, we expect to identify areas of top priority to improve the delivery of standard of care in coma patients admitted to critical care units by identifying the main barriers to implementation of cEEG. The direct impact of this study will translate into better delivery of care and improved ability to execute collaborative inter-institutional research endeavors in the future.
 
Specific aims are to:

• Determine clinical practices for patients in coma in U.S. ICUs. We hypothesize that cEEG monitoring is underutilized in coma in most centers, independent of unit type.
• Identify effects on predefined outcomes such as mortality, length of stay, and adverse effects of cEEG monitoring of coma patients. We hypothesize that utilization of goal-directed cEEG monitoring reduces mortality.
• Define specific barriers to practical implementation of cEEG in coma patients once the indication for testing has been recognized by intensive care specialists. We hypothesize that the 2 main barriers are equipment unavailability and lack of neurology EEG readers.

In-hospital cardiac arrest (IHCA) is a common and highly morbid event that impacts more than 300,000 patients in the United States each year. Despite its large public health footprint, the evidence base supporting management recommendations for patients with IHCA is small, and most society guidelines rely on evidence gathered from studies of out-of-hospital cardiac arrest (OHCA). Patients with IHCA, compared with those with OHCA, tend to have more comorbidities, have a witnessed arrest, and be treated by professional first responders with advanced monitoring and treatment capabilities. Although robust guidelines for the management of cardiac arrest and care of the post-arrest patient are generated and disseminated by the American Heart Association and other respected organizations, there are limited data regarding practice variability and adherence to recommendations across hospital systems. This is especially true for IHCA, for which the recommendations made by major organizations tend to be weaker because of less robust underlying evidence.
 
Of 30 randomized trials conducted in cardiac arrest patients between 2010 and 2014, only five trials included any IHCA patients and an even smaller number of trials were conducted exclusively in an IHCA population. It is not known whether critical findings are generalizable to inpatients. This study will help close an important knowledge gap and identify areas of improvement in the care of post-arrest inpatients.
 
In this proposal, SCCM seeks to develop a better understanding of practice variation across hospital systems with respect to IHCA resuscitation and post-resuscitation care by establishing a granular database over a six-month period that reflects current post-IHCA practices. This proposal will leverage Discovery and SCCM resources to enroll a number of varied sites and develop a database to answer important questions about post-IHCA care.
 
Inclusion criteria

• Adult patients (age ≥ 18 years)
• Patients with cardiac arrest after hospital admission
• Patients admitted to a medical ward (telemetry or non-telemetry) or an intensive care unit
• Patients who achieve initial return of spontaneous circulation (ROSC) for six hours or more or who undergo extracorporeal cardiopulmonary resuscitation (CPR) during cardiac arrest

 
Exclusion criteria

• Patients whose CPR starts outside the hospital
• Non-inpatients who have cardiac arrest (e.g., outpatients, visitors)
• Non-index arrests
• Patients with IHCA in the operating room, post-anesthesia care unit, or emergency department
• Patients with IHCA after cardiac surgery
• Cardiac arrests lasting less than two minutes (e.g., chest compressions performed for < 2 minutes)

Cardiac arrests where the patient is transitioned to comfort-focused care within six hours of ROSC

The aim of this patient-centered feasibility study on oral midodrine in early sepsis is to seek alternatives to minimize the burden of an intensive care unit (ICU) stay in these patients. Sepsis is the second leading cause of death in medical ICUs, carrying a mortality rate of 25% to 30%. Cardiovascular compromise in sepsis manifests as hypotension due to arterial vasodilation of 25% to 30%. Hypotension can persist despite initial resuscitation, prompting additional fluid boluses and subsequent central venous catheterization for the infusion of intravenous vasopressor agents. Both excess fluid boluses and central venous catheterization may expose patients to harm and discomfort.
 
Midodrine is an oral vasopressor approved for treating orthostatic hypotension. Preliminary data during the past several years suggest a markedly increased off-label use as a vasopressor-sparing agent in critically ill patients. However, no randomized trials have been conducted to evaluate the safety and efficacy of this practice. The central hypothesis is that administering oral midodrine to patients with sepsis who have received initial fluid resuscitation and appropriate antimicrobial treatment will mitigate systemic hypotension and decrease the need for additional fluids and vasopressors. The proposed multicenter pilot trial is necessary to test the feasibility of enrollment, appropriate population, timing, effect size to determine the need, and sample size for a subsequent phase II pragmatic clinical trial.

This project will support a pilot of development and deployment of a clinical practice and embedded adaptive platform for randomized clinical trials to develop safe and effective drug treatments for hospitalized patients with sepsis. A Delphi process is under way to select which medications to use for this trial. SCCM has assembled a multidisciplinary, international group to participate in the three Delphi phases: generation, prioritization, and selection. Phase 1 has been completed, with more than 300 medications generated, and phase 2 is in process.

Acute kidney injury (AKI) is a complex systemic syndrome associated with high morbidity and mortality. More than 5 million patients are admitted to hospital intensive care units (ICUs) each year in the United States. Approximately 10% of these patients have AKI requiring dialysis (AKI-D). Since January 1, 2017, healthcare law has included a provision on coverage and payment for outpatient renal dialysis services for patients with AKI. This legislation constitutes a timely and needed change in practice because it is estimated that a significant proportion of AKI-D survivors can sufficiently recover renal function without needing dialysis within the first 90 days after the initial insult. Therefore, there is an urgent need to characterize the biological natural course of AKI-D recovery and to develop clinical risk prediction models to identify patients at high risk for not significantly recovering kidney function by the time of hospital discharge.
 
This proposal is for a multicenter collaborative registry study in the ICU to 1) determine the incidence and chronologic occurrence of AKI-D recovery, 2) determine clinical parameters associated with AKI-D recovery, and 3) develop and validate risk prediction models of AKI-D recovery. The proposed study is a critical step in the development of post-AKI risk stratification tools and the identification of best practices for the optimal care of AKI-D survivors. Potential treatments will be evaluated in a randomized placebo-controlled, multicenter trial of 40 to 60 sites. Primary outcome measures will be the number of vasopressor-free days and ventilator-free days.

This study will use data form electronic health records and global registries to aggregate and analyze existing drugs that could be repurposed for critical illnesses, such as sepsis and acute kidney injury. This study will create a valuable infrastructure for collecting real-world data on critical care drug repurposing with the hope of leveraging this infrastructure beyond COVID-19. Study objectives are to establish a disease-agnostic, real-world data repository to support drug repurposing in critical care; facilitate the dissemination of the Observational Health Data Sciences and Informatics (OHDSI)/Perseus tool stack for data harmonization; curate large, high-quality, de-identified datasets on diseases and conditions of high unmet clinical need; and promote near-real-time, high-quality, observational research. SCCM will be the data coordinating center for this study.

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Pauline K. Park, MD, FCCM
 
Approximately one-quarter of patients with acute respiratory distress syndrome (ARDS) develop severe hypoxemia (Pao2/Fio2 < 100). In large series, severe hypoxemia has been associated with high observed mortality rates, approximating 40%-50%. The severity of hypoxia in the majority of these patients is established at initial presentation, suggesting an opportunity for early intervention. The development of strategies to reduce mortality is hampered by the difficulty of conducting randomized trials in this population.
 
While a number of interventions for ARDS have been shown in randomized, controlled trials to lead to improved outcomes, studies to date indicate that the use of these evidence-based practices is highly variable and inconsistent. At the same time, unproven treatment modalities are commonly used in the management of ARDS. The SAGE study was conducted to evaluate current U.S. practices in the management of severe ARDS, both to inform practicing clinicians and to form the basis for future research.
 
Objective: Assessment of early management of severe ARDS, including ventilator management and use of rescue therapy.
 
Specific aims:

• Describe U.S. management practices and variation in the use of ventilator strategies and rescue modalities in patients with severe ARDS
• Determine prospectively the factors in early severe ARDS associated with survival or need for adjuvant therapy
• Evaluate characteristics, management, and survival in patients admitted to SAGE centers compared with patients transferred to SAGE centers from other sites
• Determine the variability in the use of tidal volume and positive end-expiratory pressure and its association with subsequent mortality among patients with severe ARDS on extracorporeal membrane oxygenation

Design: multicenter, prospective, observational cohort study conducted through participating sites between October 2016 and April 2017
 
 Inclusion criteria:

• Age above 18 years
• Patients with acute respiratory failure in the intensive care unit requiring invasive mechanical ventilation
• Presence of severe ARDS

Intensive care resources are limited, while the number of patients needing intensive care is increasing. It is recognized that, among patients admitted to intensive care units (ICUs), many do not require intensive care but are admitted for close monitoring. Intermediate care units (IMCUs), also known as high-dependency units, step-down units, or progressive care units, were created to accommodate patients who do not require intensive care but whose needs surpass the care and monitoring feasible on a general ward. Patients may be transitioned to an IMCU after being stabilized in an ICU or having worsened on a general ward or may be directly admitted from the emergency department or post-anesthesia care unit.
 
Over the past 20 years, billing for intermediate care and the prevalence of IMCUs have increased. However, the optimal staffing structure, physical layout, and admission guidelines for these units are not well defined. This heterogeneity, complicated by differences in regional needs, institutional missions, clinical expertise, physical resources, and characteristics of the patients they serve, has resulted in limited generalizability of IMCU patient outcomes and cost effectiveness studies. A better understanding of IMCU organizational structure paired with patient outcomes would greatly inform future IMCU use. This study will investigate variability in the structure and use of IMCUs in different regions and centers. Investigators will survey centers to characterize the current structure of intermediate care in the United States.

Jen-Ting Chen, MD
 
While fluid resuscitation is a mainstay of treatment for most patients with shock, excessive volume resuscitation is associated with worse clinical outcomes. Many studies have shown that dynamic hemodynamic measurements can predict fluid responsiveness, but little is known about their association with important clinical outcomes. The overall goal of VOLUME-CHASERS is to conduct a multicenter, observational cohort study across a broad range of hospitals, including patients in the emergency department, intensive care unit (ICU), and non-ICU areas, to determine the variability in shock resuscitation and modalities used to determine the amounts of fluid and doses of vasopressor administered. We will explore the possible outcome differences associated with this variability in practice.

The purpose of this project is to determine the predominant sedation strategies for patients with acute respiratory failure (ARF) requiring mechanical ventilation (MV) and obtain consensus on sedation strategies for future research through a modified Delphi panel. MV provides respiratory support to more than 1 million patients annually in the United States with ARF. Guidelines for management of analgesia and sedation during MV recommend an opioid-based analgesia-first approach, which differs markedly from recommendations to reduce opioid prescribing and associated risks for long-term opioid use across most other clinical settings. However, optimal sedation and analgesia strategies to maintain patient comfort during MV while minimizing short-term (delirium, prolonged mechanical ventilation) and long-term (persistent opioid use, readmissions, day alive and out of institution) risks are unclear. Multiple knowledge gaps remain before opioid-sparing strategies during ARF can be prospectively tested, including more precise classification of current sedation-analgesia practice patterns. As part of the broader project proposal, Mitigating Sedative-Related Risk in the Management of Acute Respiratory Failure, which will use machine-learning-based hierarchical clustering methods across multiple data sets to classify sedation practice in the United States, we propose a multidisciplinary Delphi panel of SCCM members to provide additional input to contextualize the quantitative findings from our hierarchical clustering and reach consensus on future directions in sedation comparative effectiveness research. We seek a partnership with Discovery to assist with recruitment of ICU physicians, nurses, pharmacists, respiratory therapists, and possibly patient groups for the Delphi panel.

Prone positioning, the coordinated turning of a patient from supine (lying on their back) to prone (lying on their chest), is strongly recommended in joint society guidelines as a cost-effective therapy that reduces mortality among patients with moderate to severe acute respiratory distress syndrome. Safe and effective prone positioning of patients receiving invasive mechanical ventilation (intubated prone positioning) requires multidisciplinary coordination and training. We propose that intubated prone positioning should be classified as a clinical procedure with an assigned International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS) code, and we seek SCCM's support for our application to the Centers for Medicare and Medicaid Services. Designating intubated prone positioning with a procedure code may have several benefits, including improved epidemiologic surveillance and research; increased adherence to an underused, guideline-recommended intervention; and accounting by hospital administration to ensure availability of specific clinical expertise, materials, and staffing necessary to safely perform prone positioning.

This study aims to address the lack of a national ICU clinical quality registry in the United States by creating Accelerated Quality Improvement and Research (ACQUIRE), a standard platform integrating quality improvement and clinical research to enhance patient care. The innovative ACQUIRE standard is designed to be electronic health record vendor neutral and serve as the data science foundation for SCCM's Centers of Excellence clinical quality registry. Through the three key aims of feasibility, scalability, and sustainability, ACQUIRE seeks to improve clinical outcomes by examining the interaction between social determinants of health and bundle components. This initiative not only promotes inclusivity and fairness in critical care decision-making processes but also sets a precedent for data-driven care improvement projects and research in critical care medicine.

One Day in the ICU seeks to collect up-to-date data on ICU patient demographics and characteristics across the United States, quantify patient demographics, identify healthcare disparities, inform research and quality improvements, validate medical devices and AI algorithms, and set ICU performance benchmarks. Using a cross-sectional design, the study will gather de-identified electronic medical record data through an online survey completed on a predetermined day. These data will include information on hospital and ICU characteristics, staffing, patient demographics, and levels of care, all crucial data amid a significantly changed healthcare landscape due to the lack of recent data since 1993. By providing current and comprehensive data, the study aims to enhance healthcare equity and outcomes for ICU patients in the United States.

Understanding Patient and Family Perspectives on Clinician Racial Bias in End-of-Life Care and Its Impact on Trust and Goals of Care in the ICU aims to investigate the impact of racial bias on end-of-life (EOL) care for Black and Hispanic ICU patients. By assessing implicit bias among clinicians and understanding the experiences of affected patients and families, the study will explore how these factors influence trust and care decisions. The goal is to develop racially unbiased recommendations for EOL care through community and professional stakeholder input. Ultimately, this research seeks to address disparities in EOL care by amplifying patient voices and informing clinician practices.

A Platform for Healthcare Data Integration Using Blockchain and Artificial Intelligence
This project utilizes blockchain and artificial intelligence to provide integrated healthcare systems with a seamless, secure, and interoperable data platform, aiming to improve patient outcomes, reduce costs, and ensure compliance with privacy and security requirements. SCCM will serve as the coordinating center, overseeing the integration of two sites to demonstrate data interoperability in severe respiratory disease research. The project includes tasks such as developing connectors for SCCM-managed sites, utilizing a datamart for business intelligence, and implementing an institutional review board approval smart contract.

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