Aquadex Pediatric Treatment Study Shows Positive Results
New registry results support expanded therapy use for pediatric patients weighing as little as five kilograms.
Updated on Oct. 27, 2026 in Children’s Health
The journal Pediatric Nephrology published the ULTRA-Peds Registry study, which evaluated Aquadex therapy outcomes in 91 pediatric patients at seven children's hospitals. The study reports an 87% patient survival rate during the treatment course.
Why it matters
The registry provides critical clinical evidence for using Aquadex in pediatric patients weighing less than 10 kg. Nuwellis intends to use this data to support a proposed label expansion for the device to include patients weighing 5 kg and above.
Researchers evaluated clinical outcomes across a total of 208 pediatric patients, with 86.5% of procedures completed without interruption. Approximately 68% of cases with complete data lasted the planned treatment duration.
The players
Nuwellis, Inc.
This Minneapolis-based medical device company specializes in the development of technologies for fluid management.
Acute Kidney Injury Critical Care Research Foundation
This organization receives grants to facilitate research into clinical outcomes for pediatric patients with kidney injury.
Watermark Partners
This Indianapolis-based entity managed the data collection and operational oversight for the study.
Stuart Goldstein
He serves as the Director of Clinical Strategy and is a key figure involved in the organization's research initiatives.
The details
The study examined patient outcomes, treatment characteristics, and device performance metrics, including blood flow rates and circuit duration. Of the 91 patients evaluated, 41 weighed less than 5 kg, while 62% of the total cohort weighed less than 10 kg.
Timeline
The ULTRA-Peds Registry opened in March 2021.
Stuart Goldstein was announced as Director of Clinical Strategy in March 2026.
Study results were published in the journal Pediatric Nephrology on October 27, 2026.
Health Landscape
The clinical findings challenge the long-standing 20 kg minimum patient weight threshold currently required for Aquadex therapy. This study shifts the paradigm toward providing specialized fluid management options for the most vulnerable neonates and infants.
If the proposed label expansion is approved, infants weighing as little as 5 kg may gain access to Aquadex therapy for fluid management. This development could broaden treatment options for physicians managing critical care cases in pediatric hospitals.
The takeaway
The ULTRA-Peds Registry demonstrates the feasibility of utilizing established fluid management technology in smaller pediatric patients. These findings emphasize the importance of registry studies in safely expanding the clinical application of medical devices for specialized populations.
Further reading
For more information on ongoing clinical research, visit the Children’s Health section.
Source note: This article includes information reported by The Manila times.
