NCT04644731 (ULTRA-Peds) is a clinical trial of Aquadex™ System in Fluid Overload, sponsored by Nuwellis, Inc..

Who is sponsoring NCT04644731?

NCT04644731 is sponsored by Nuwellis, Inc..

What drugs are being tested in NCT04644731?

Interventions in NCT04644731: Aquadex™ System.

What condition does NCT04644731 study?

NCT04644731 studies Fluid Overload.

Is NCT04644731 still recruiting?

NCT04644731 is currently terminated. Last updated 20 February 2024.

Last reviewed 2024-02-20 · How we verify

NCT04644731: ULTRA-Peds

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Ultrafiltration Therapy Registry Using Aquadex (ULTRA-Peds)

Terminated Last updated 20 February 2024

What this trial tests

trial testing Aquadex™ System in Fluid Overload in 97 participants. Terminated before completion.

Timeline

9 April 2021

Primary endpoint
13 September 2023

13 September 2023

Quick facts

Lead sponsor	Nuwellis, Inc.
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	97
Start date	9 April 2021
Primary completion	13 September 2023
Estimated completion	13 September 2023
Sites	7 locations across United States

Drugs / interventions tested

Aquadex™ System

Conditions studied

Fluid Overload — all drugs for Fluid Overload →

Sponsor

Nuwellis, Inc. — full company profile →

Who can join

Under 21, any sex, with Fluid Overload. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Fluid assessment, fluid balance, and fluid overload in sick children: a report from the Pediatric Acute Disease Quality Initiative (ADQI) conference.
Selewski DT, Barhight MF, Bjornstad EC, Ricci Z, et al · · 2024 · cited 34× · PMID 37934274 · DOI 10.1007/s00467-023-06156-w

Verify or expand the search:

Other recruiting trials for Fluid Overload

Currently open trials in the same condition.

NCT03629977 — Timing of Renal Replacement Therapy in the Critically Ill Patients · recruiting
NCT07275658 — Timing and Dose of Fluid Deresuscitation in Critically Ill Patients · recruiting
NCT06697470 — Muscle and Subcutaneous Tissue Variation by Ultrasound and Impedance Linked to Fluid Balance in ICU Patients · recruiting
NCT06539026 — Inferior Vena Cava Collapsibility Index Guide for Preoperative Fluid Therapy in Preeclampsia · NA · recruiting
NCT06418022 — Evaluating Fluid Responsiveness in ICU Patients Using VTI and Trendelenburg Positioning · NA · recruiting

Other Nuwellis, Inc. trials

Trials by the same sponsor.

NCT05318105 — Ultrafiltration Versus IV Diuretics in Worsening Heart Failure · NA · recruiting
NCT04241718 — A Feasibility Study on Ultrafiltration and Blood Volume Measurements · NA · terminated
NCT01872949 — C-Pulse® System European Multicenter Study · completed
NCT01740596 — C-Pulse® System: A Heart Assist Device Clinical Study · NA · terminated
NCT01176370 — C-Pulse Implantable Counterpulsation Pump (ICP) - A Heart Assist Device · NA · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04644731 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Nuwellis, Inc.
Last refreshed: 20 February 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04644731.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing