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Terminated No phase listed Observational

Ultrafiltration Therapy Registry Using Aquadex (ULTRA-Peds)

ClinicalTrials.gov ID: NCT04644731

Public ClinicalTrials.gov record NCT04644731. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 4:45 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

ULTRA-Peds: A Multicenter Data Registry for Outcomes for Pediatric Volume Overload

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04644731
Recruitment status
Terminated
Study type
Observational
Phase
Not listed
Lead sponsor
Nuwellis, Inc.
Industry
Enrollment
97 participants

Conditions and interventions

Conditions

Interventions

Device

Eligibility (public fields only)

Age range
Up to 21 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 8, 2021
Primary completion
Sep 12, 2023
Completion
Sep 12, 2023
Last update posted
Feb 19, 2024

2021 – 2023

United States locations

U.S. sites
7
U.S. states
7
U.S. cities
7
Facility City State ZIP Site status
Children's of Alabama Hospital Birmingham Alabama 35233
Lucile Packard Children's Hospital Stanford Palo Alto California 94304
Joe DiMaggio Children's Hospital Hollywood Florida 33021
Riley Children's Hospital Indianapolis Indiana 46202
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229
Le Bonheur Children's Hospital Memphis Tennessee 38105
Seattle Children's Hospital Seattle Washington 98105

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04644731, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 19, 2024 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04644731 live on ClinicalTrials.gov.

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