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This podcast discusses patients who develop acute kidney injury (AKI) and how AKI is independently associated with mortality in critically ill infants, neonates, and larger children. Host Pamela M. Peeke, MD, MPH, FACP, FACSM, is joined by Stuart Goldstein, MD, to discuss the HF20 study, including its end points and the clinical gaps the study addresses. (Munshi R, et al. Pediatr Nephrol 2020 Dec;35:2345-2352)
Dr. Goldstein is a professor of pediatrics and director of the Center for Acute Care Nephrology at Cincinnati Children's Hospital Medical Center in Cincinnati, Ohio, USA. This podcast is sponsored by Baxter Healthcare.
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Transcript:
This podcast is sponsored by Baxter Healthcare Corporation. When you choose Baxter for your CRRT program, you’re not only choosing true patient-focused treatment with industry-leading CRRT technology, you’re also selecting a partner dedicated to optimizing your clinical success in treating patients with acute kidney injury. Our commitment to you starts with the program individualized to your facility’s needs and provides complete support every step of the way. For more information, visit us at www.renalacute.com.
Baxter Healthcare Corporation has provided funding for this podcast, but all content was developed independently by the presenter. Therefore, the views expressed on the podcast are those of the speaker and should not be attributed to Baxter Healthcare Corporation.
For prescription use only. For the safe and proper use of this product, please refer to the operator’s manual.
The PRISMAFLEX HF20 Set has been authorized by the FDA under an Emergency Use Authorization to provide continuous renal replacement therapy (CRRT) to treat low weight (8-20 kg) and low blood volume patients or patients who have acute renal failure, fluid overload, or both and who cannot tolerate a larger extracorporeal circuit volume in an acute care environment during the coronavirus disease 2019 (COVID-19) pandemic. The PRISMAFLEX HF20 Set has been neither cleared nor approved to provide CRRT in an acute care environment. The PRISMAFLEX HF20 Set is authorized for use for no longer than the duration of the COVID-19 public health emergency, as deemed by the Secretary of the Department of Health and Human Services (HHS).
Pamela M. Peeke, MD, MPH, FACP, FACSM (Host): Hello and welcome to the Society of Critical Care Medicine’s iCritical Care podcast. I’m Dr. Pam Peeke, your host. Today, we’re talking about continuous renal replacement therapy (CRRT) in children. I’m joined by Stuart Goldstein, MD, professor of pediatrics and director of the Center for Acute Care Nephrology at Cincinnati Children’s Hospital Medical Center. Dr. Goldstein received his medical degree from Columbia University and completed both clinical and research fellowships in pediatric nephrology at the Children’s Hospital in Boston, Massachusetts, USA. He is the founder and principal investigator for the Prospective Pediatric Acute Kidney Injury Research Group and has evaluated novel urinary AKI biomarkers in the pediatric critical care setting. He has written over 300 journal articles, served as editor of two textbooks, and contributed multiple book chapters. Dr. Goldstein, welcome to the podcast.
Dr. Goldstein: Thank you so much, Dr. Peeke.
Dr. Peeke: Before we begin, do you have any disclosures to report?
Dr. Goldstein: Yes. I served as a consultant for Baxter Healthcare and also receive grant support from Baxter Healthcare. Baxter is the maker of the HF20 CRRT filter.
Dr. Peeke: Thank you. In your estimation, why is this podcast needed?
Dr. Goldstein: I think what’s really important is that, for many, many years, there have been no devices specific to the most critically ill children who require continuous dialysis or CRRT. Pediatricians in ICUs, both intensivists and nephrologists, have had to use devices off-label and have had to adapt those devices to kids. We know from work that we and others have performed that acute kidney injury (AKI) is independently associated with mortality for critically ill infants, neonates, and larger children. Part of what we found in the past decade is that kids who weighed less than 10 or 20 kilos have increased mortality if they develop AKI and require CRRT. So I believe this podcast is important because the HF20 filter addresses an important gap in the care of children. It is aimed at supporting children who weigh 8 to 20 kilos. There has not been another device available for them. This device has been available in Europe for many years and is currently available in the United States under an emergency use authorization (EUA) for COVID-19. This is why I think it is important to let people know about this device.
Dr. Peeke: What are the knowledge gaps? What’s going on out there in the real world, in the ICU, as it pertains to children who need this type of therapy?
Dr. Goldstein: I think it’s not so much a knowledge gap as it is a financial gap. These are orphan diseases in terms of how the FDA perceives them and the way that we think about them. As opposed to adult medicine, there are fewer than 4000 to 8000 children in the United States who require CRRT annually. And when you slice that pie even smaller, for kids under 20 kilos, it becomes less than about 30% of those patients. So there has not been the financial return on investment to think about developing devices that are specific for this incredibly vulnerable population.
Fortunately though, over the past 5 to 10 years, there has been a push to provide devices, including the HF20, that are specific to smaller children. And that has a huge impact on them because, with larger devices, we often have to prime the circuit with blood to allow and promote hemodynamic stability for smaller patients. If you use a large adult filter and you don’t prime that filter with blood, you can cause anemia and hemodynamic instability.
So what’s the big deal about blood priming? The big deal is that we now start to sensitize some patients who are not going to recover their kidney function and therefore decrease the donor pool for available kidney transplant donors for these patients. Therefore, having devices that are specifically made for smaller kids allows us to avoid blood priming, blood exposure, sensitization, and even potential infections from the donor supply.
Dr. Peeke: Could you talk a little bit about the US HF20 study itself and its end points?
Dr. Goldstein: The HF20 study, which was funded by Baxter, was a five-center prospective study of the HF20 for children who weighed 8 to 20 kilos and required CRRT as part of their standard of care. The platform is the Prismaflex platform, which can use filters of larger size but is also programmable for the HF20. The goal was to enroll about 20 patients across five centers, with two major end points. One end point was efficacy, which was determined with the FDA to be a 38% reduction in blood urea nitrogen over the first 24 hours of CRRT therapy. The second were safety end points of tolerability, hemodynamic tolerability, platelet counts, anemia, etc.
What we found was, with the first 17 patients treated, 100% of them had 38% reduction in blood urea nitrogen. There were no allergic reactions. There were no device-related unanticipated complications or serious adverse events. We published our experience with the US HF20 study in the Journal of Pediatric Nephrology in 2020. Raj Munshi, MD, is the first author of that paper.
Dr. Peeke: Excellent. What clinical gaps does the HF20 specifically address? And why are these so important for children?
Dr. Goldstein: The gaps are: The software that is used for the HF20 allows more precise fluid balance parameters, instead of larger changes, say, in fluid removal in mL/hr. Their smaller increments allow us to be more precise for smaller kids. Again, we don’t have to blood prime the circuit as often down to about 11 to 12 kilos. So we don’t sensitize patients to different blood antigens and we don’t cause the iron overload that’s often associated with repeat blood priming.
The way the study was designed was that children would only be able to use the HF20 as the first filter during the CRRT course. Patients are often on CRRT for many, many filters for many, many days. And when we had to switch away from the HF20 to larger filters, the bedside nurses, clinicians, and parents were dismayed that we had to go to a larger filter and then blood prime for the patient. So what it also does is demonstrate that there is a filter and a technology that’s made for these patients, which is what they deserve.
Dr. Peeke: Give us some examples of what would cause this need for CRRT in a child.
Dr. Goldstein: About 27% of all children admitted to ICUs around the world develop AKI. We demonstrated this in a multicenter study called AWARE, which was published in the New England Journal of Medicine. This has also been shown by David Askenazi, MD, in the neonatal AWAKEN study.
We also demonstrated that the development of a doubling of serum creatinine or 12 hours of oliguria are independently associated with mortality in children. These are novel findings. It’s been very difficult in adults to disentangle the chronic comorbidities of COPD, obesity, diabetes, chronic kidney disease. Children generally don’t have these comorbidities, so this demonstrated that AKI is key in mediating the mortality and also length of stay and time on the ventilator. Requiring renal replacement therapy also was one of the most predictive factors for 28-day mortality.
The number one cause by far, just as in adults, is sepsis. Number two is shock, both with and without sepsis. And number three is the additive effects of nephrotoxic medications that are often needed to treat the underlying diseases. What we’re learning is that starting renal replacement therapy earlier in children at earlier levels of fluid overload and accumulation may be associated with improved outcomes. But when you don’t have a technology that is designed specifically for smaller children, there may be a reticence to start CRRT earlier.
In children, as opposed to adults, CRRT is the most common initial therapy for critically ill children with AKI. So we really need to support these children while their kidney function hopefully recovers and they recover from their underlying illness.
Dr. Peeke: What has been your own experience with utilizing the HF20?
Dr. Goldstein: We utilized the HF20 as part of the study. Then Baxter received an EUA for the HF20 during the COVID pandemic. What was important about that EUA was that it was not restricted to patients with COVID; it was just restricted to small patients with AKI.
So we have been using the HF20 quite frequently during the pandemic and are continuing to do so. We’ve received another grant from Baxter to develop a registry for all of the centers in the United States that are using the HF20 during the pandemic so we can hopefully develop enough data that this can be used for small children once the pandemic is over.
We’ve learned that we may need to be a little bit more aggressive with anticoagulation with the HF20, because the blood flows are slower and the filter is smaller, so the risks for clotting may be a little bit higher. But other than that, we haven’t had to do anything in terms of changing our practice. We’ve now been able to treat these kids as aggressively as we do larger children.
Dr. Peeke: Have you seen changes in morbidity and mortality with the HF20?
Dr. Goldstein: It’s too early to tell. This is what we’re hoping to see in our larger study under the EUA.
Dr. Peeke: But you’re hopeful.
Dr. Goldstein: Yes, I’m very hopeful. An earlier collaborative that I ran with Dr. David Askenazi as the first author, called the Prospective Pediatric CRRT Registry Group, demonstrated that survival was lower, about 40%. ICU survival was about 40% for kids under 10 kilos and 60% for kids over 10 kilos. We’re very hopeful that this technology for the weight range between 10 to 20 kilos will be associated with improved outcomes.
Dr. Peeke: Excellent. If you were to improve the HF20, what would you do? What more do you want from this technology?
Dr. Goldstein: What we would really like is to be able to have smaller filters for other types of therapies using, say, the Prismaflex backbone. There are other extracorporeal filter-based therapies, a number of which many of us are working on, which would be great to be able to package in with the HF20. That’s what I’d really like to see—multiple organ support therapy. Nephrologists who practice critical care nephrology, intensivists who perform CRRT, and most importantly the nurses, are expert at handling these extracorporeal therapies. I would love for it to not take 20 years for smaller filters with these varying technologies to be available for kids in the United States.
Dr. Peeke: Fantastic. Any last words of wisdom to your colleagues out there who may be new to this technology with HF20?
Dr. Goldstein: What I would say is don’t be afraid. There is a whole community in pediatric acute care nephrology who are willing to share our protocols, our thoughts, what we have found that has worked. Not to say that what we do in Cincinnati is best, but we know why we do what we do. We know what has worked for us and what has not. One of our missions in the Prospective Pediatric AKI Research Group is to help educate centers that are thinking about starting up and also to provide resources so they don’t have to reinvent the wheel. They should learn from our successes as well as our challenges and mistakes.
Dr. Peeke: Fantastic. You have articulated the use of the HF20 and its value in the intensive care therapy of children, where before we did not have this kind of technology, and it has most definitely impacted morbidity and mortality. Can people reach out to you if they have questions?
Dr. Goldstein: Anytime. They know how to find me.
Dr. Peeke: Thank you so much, Dr. Goldstein, for sharing your wisdom about the HF20, its use, and its history. This concludes another edition of the iCritical Care podcast. For the iCritical Care podcast, I’m Dr. Pam Peeke.
This podcast is sponsored by Baxter Healthcare Corporation. When you choose Baxter for your CRRT program, you’re not only choosing true patient-focused treatment with industry-leading CRRT technology, you’re also selecting a partner dedicated to optimizing your clinical success in treating patients with acute kidney injury. Our commitment to you starts with the program individualized to your facility’s needs and provides complete support every step of the way. For more information, visit us at www.renalacute.com.
Baxter Healthcare Corporation has provided funding for this podcast, but all content was developed independently by the presenter. Therefore, the views expressed on the podcast are those of the speaker and should not be attributed to Baxter Healthcare corporation.
For prescription use only. For the safe and proper use of this product, please refer to the operator’s manual.
The PRISMAFLEX HF20 Set has been authorized by the FDA under an Emergency Use Authorization to provide continuous renal replacement therapy (CRRT) to treat low weight (8-20 kg) and low blood volume patients or patients who have acute renal failure, fluid overload, or both, and who cannot tolerate a larger extracorporeal circuit volume in an acute care environment during the coronavirus disease 2019 (COVID-19) pandemic. The PRISMAFLEX HF20 Set has been neither cleared nor approved to provide CRRT in an acute care environment. The PRISMAFLEX HF20 Set is authorized for use for no longer than the duration of the COVID-19 public health emergency, as deemed by the Secretary of the Department of Health and Human Services (HHS).
Pamela M. Peeke, MD, MPH, FACP, FACSM, is a nationally renowned physician, scientist, expert, and thought leader in the field of medicine. Dr. Peeke is a Pew Foundation scholar in nutrition and metabolism and assistant professor of medicine at the University of Maryland. She holds dual master’s degrees in public health and policy and is a fellow of both the American College of Physicians and American College of Sports Medicine.
Dr. Peeke has been named one of America’s top physicians by the Consumers’ Research Council of America. She is a regular in-studio medical commentator for the national networks and an acclaimed TEDx presenter and national keynote speaker. Dr. Peeke is a three-time New York Times-bestselling author and a science and health advisor for Apple.
The iCritical Care podcast is the copyrighted material of the Society of Critical Care medicine. All rights are reserved. Statements of fact and opinion expressed in this podcast are those of authors and participants, and do not imply an opinion or endorsement on the part of the Society of Critical Care medicine, its officers, volunteers or members, or that of the podcast commercial supporter.
Some episodes of the iCritical Care Podcast include a transcript of the episode’s audio. Although the transcription is largely accurate, in some cases it is incomplete or inaccurate due to inaudible passages or transcription errors and should not be treated as an authoritative record.
