Ultrafiltration Therapy Registry Using Aquadex (ULTRA-Peds)

Fluid Overload Clinical Trial

— ULTRA-Peds  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04644731
• Other study ID #: CLIN07423
• Status: Terminated
• Start date: April 9, 2021
• Est. completion date: September 13, 2023

Study information

• Verified date: February 2024
• Source: Nuwellis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 97
• Est. completion date: September 13, 2023
• Est. primary completion date: September 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Fluid Overload

Intervention

Device:
• Aquadex™ System
Ultrafiltration for fluid removal

Locations

Country	Name	City	State
United States	Children's of Alabama Hospital	Birmingham	Alabama
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Joe DiMaggio Children's Hospital	Hollywood	Florida
United States	Riley Children's Hospital	Indianapolis	Indiana
United States	Le Bonheur Children's Hospital	Memphis	Tennessee
United States	Lucile Packard Children's Hospital Stanford	Palo Alto	California
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Nuwellis, Inc.	AKI Critical Care Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Survival	Patient survive treatment course	Through completion of a treatment course, up to 3 months
Primary	Survival at ICU discharge	% of ICU patients survive treatment in ICU	Through completion of a treatment course in the ICU, up to 1 month
Primary	Change in Kidney Function	Assessment of Kidney function	Change eGFR and renal labs from initiation to completion of treatment, up to 3 months
Primary	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
Primary	Hemodynamic stability during treatment course	Need for vasoactive medication	Through completion of a treatment course, up to 3 months
Primary	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
Primary	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
Primary	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
Primary	Aquadex related adverse events	Aquadex related adverse events	Through completion of a treatment course, up to 3 months