Ultrafiltration Therapy Registry Using Aquadex (ULTRA-Peds)

NCT04644731 | Terminated FDA Device

• 1 other identifier: CLIN07423
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 7

Brief 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

Outcome Measures

Primary Outcomes (9)

• Treatment Survival

  Patient survive treatment course

  Through completion of a treatment course, up to 3 months

• Survival at ICU discharge

  % of ICU patients survive treatment in ICU

  Through completion of a treatment course in the ICU, up to 1 month

• Change in Kidney Function

  Assessment of Kidney function

  Change eGFR and renal labs from initiation to completion of treatment, up to 3 months

• Hemodynamic stability at initiation of UF therapy

  Need resuscitation fluids and medications (e.g. vasoactive medication)

  From the time of index procedure is initiated up to 60 minutes after initiation

• Hemodynamic stability during treatment course

  Need for vasoactive medication

  Through completion of a treatment course, up to 3 months

• Change % fluid overload during treatment course

  % change in weight from initiation to the end of the last Aquadex procedure

  Through completion of a treatment course, up to 3 months

• Length of Stay in ICU

  Time of admission to ICU to discharge

  The time from admission to ICU through discharge from ICU, usually 1 month

• Change in PRISM III Score

  Physiologic variables and labs to assess mortality risk

  2 hours before ICU admission through the first 4 hours after ICU discharge

• Aquadex related adverse events

  Aquadex related adverse events

  Through completion of a treatment course, up to 3 months

Study Arms (1)

Pediatric patients who require fluid removal

Pediatric patients who require fluid removal with the Aquadex™ System per local standard of care

Device: Aquadex™ System

Interventions

Aquadex™ System DEVICE

Ultrafiltration for fluid removal

Pediatric patients who require fluid removal

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients who require fluid removal with the Aquadex™ System per local standard of care

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

Sponsors & Collaborators

• Nuwellis, Inc.: lead
• AKI Critical Care Research Foundation: collaborator

Study Sites (7)

Children's of Alabama Hospital

Birmingham, Alabama, 35233, United States

Location

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

Location

Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021, United States

Location

Riley Children's Hospital

Indianapolis, Indiana, 46202, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Le Bonheur Children's Hospital

Memphis, Tennessee, 38105, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stuart Goldstein, MD

  AKI Critical Care Research Foundation

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 90 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 25, 2020
• Study Start: April 9, 2021
• Primary Completion: September 13, 2023
• Study Completion: September 13, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

US (7)