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Ultrafiltration Therapy Registry Using Aquadex (ULTRA-Peds)

NCT04644731 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 97

Last updated 2024-02-20

No results posted yet for this study

Summary

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.

Conditions

  • Fluid Overload

Interventions

DEVICE

Aquadex™ System

Ultrafiltration for fluid removal

Sponsors & Collaborators

  • AKI Critical Care Research Foundation

    collaborator OTHER

  • Nuwellis, Inc.

    lead INDUSTRY

Principal Investigators

  • Stuart Goldstein, MD · AKI Critical Care Research Foundation

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-09
Primary Completion
2023-09-13
Completion
2023-09-13
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04644731 on ClinicalTrials.gov