Ultrafiltration Therapy Registry Using Aquadex (ULTRA-Peds)
Stopped early
Conditions studied: Fluid Overload
In brief
The ULTRA-Peds registry will employ a multi-center, single-arm, open-label, observational design to capture baseline, procedural and follow-up data on pediatric patients that have been treated (i.e., retrospective data from treatment at the time of registry approval by the IRB) or are scheduled to be treated (i.e., prospective data for on-label treatment after registry approval by the IRB) with Aquadex therapy according to local standard of care practices and decisions. All prospective data will be from on-label Aquadex treatment of pediatric patients weighing 20 kilograms or more. No data from prospective off-label treatment (i.e., Aquadex treatment with other adjunctive or conjunctive therapies for pediatric patients who may weigh less than 20kg) will be included in the registry. An estimated 10 sites in the United States who have received training in extracorporeal therapy and the Aquadex™ system will enroll a minimum of 500 patients.
Key facts
- Study ID
- NCT04644731
- Run by
- Nuwellis, Inc.
- People needed
- 97
- Starts
- 2021-04-09
- Expected to finish
- 2023-09-13
- Last updated by the study team
- 2024-02-20
Who can join
Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- I. For enrollment in prospective data collection:
- Patient age is 21 years or younger
- Patient weighs 20 kilograms or more.
- Patient or legally authorized representative provides written authorization or patient is hospitalized and receiving treatment in a center with an Institutional Review Board that has allowed for waived consent based on the type of data being collected for the Registry.
- Patient is to undergo Aquadex therapy for fluid overload (i.e., fluid removal) as local standard of care.
- II. For enrollment in retrospective data collection:
- Patient age is 21 years or younger.
- Patient or legally authorized representative provides written authorization or patient is hospitalized and receiving treatment in a center with an Institutional Review Board that has allowed for waived consent based on the type of data being collected for the Registry.
- Patient underwent Aquadex therapy for fluid overload (i.e., fluid removal) as local standard of care.
You may not qualify if…
- Unable or unwilling to provide informed consent
- Unable or unwilling to comply with study requirements
Where it is running
- Children's of Alabama Hospital — Birmingham, Alabama, United States
- Lucile Packard Children's Hospital Stanford — Palo Alto, California, United States
- Joe DiMaggio Children's Hospital — Hollywood, Florida, United States
- Riley Children's Hospital — Indianapolis, Indiana, United States
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
- Le Bonheur Children's Hospital — Memphis, Tennessee, United States
- Seattle Children's Hospital — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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