Ultrafiltration Therapy Registry Using Aquadex (ULTRA-Peds) (ULTRA-Peds)

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

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 Overview

• Status: Terminated
• Conditions: Fluid Overload
• Intervention / Treatment: Device: Aquadex™ System

Detailed Description

The ULTRA-PEDs registry is designed to capture data in the real-World clinical setting on the Aquadex™ system in local standard of care, with the aim of understanding it's performance and utilization. Enrollment is expected to take approximately 2.5 years from the time the first patient is enrolled to the time the final patient is discharged from the hospital.

ULTRA-PEDs will allow prospective and retrospective data collection for the following scenarios:

• All prospective data for on-label use only (i.e., Aquadex ultrafiltration therapy for pediatric patients weighing 20 kg or more, whose fluid overload is unresponsive to medical management, including diuretics).

• Retrospective patients at the time of registry approval by IRB regardless of on-label or off-label use.

  • Retrospective on-label use
  • Retrospective off-label use (i.e., Aquadex ultrafiltration with other adjunctive or conjunctive therapies for pediatric patients who may weigh less than 20kg)

• Study Type: Observational
• Enrollment (Actual): 97

Contacts and Locations

• Study Contact: Name: Megan Cease; Phone Number: 952-345-4217; Email: megan.cease@nuwellis.com

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Children's of Alabama Hospital
  • California
    • Palo Alto, California, United States, 94304
      • Lucile Packard Children's Hospital Stanford
  • Florida
    • Hollywood, Florida, United States, 33021
      • Joe DiMaggio Children's Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Riley Children's Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • Le Bonheur Children's Hospital
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 21 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

I. For enrollment in prospective data collection:

1. Patient age is 21 years or younger
2. Patient weighs 20 kilograms or more.
3. 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.
4. 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:

1. Patient age is 21 years or younger.
2. 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.
3. Patient underwent Aquadex therapy for fluid overload (i.e., fluid removal) as local standard of care.

Exclusion Criteria:

1. Unable or unwilling to provide informed consent
2. Unable or unwilling to comply with study requirements

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pediatric patients who require fluid removal; Pediatric patients who require fluid removal with the Aquadex™ System per local standard of care	Device: Aquadex™ System; Ultrafiltration for fluid removal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Nuwellis, Inc.
• Collaborators: AKI Critical Care Research Foundation
• Investigators: Study Chair: Stuart Goldstein, MD, AKI Critical Care Research Foundation

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2021
• Primary Completion (Actual): September 13, 2023
• Study Completion (Actual): September 13, 2023

Study Registration Dates

• First Submitted: November 10, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 25, 2020

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CLIN07423

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes