NCT04644731

Ultrafiltration Therapy Registry Using Aquadex (ULTRA-Peds)

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 97 (actual)
• Sponsor: Nuwellis, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

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)

Conditions

• Fluid Overload

Interventions

Type	Name	Description
DEVICE	Aquadex™ System	Ultrafiltration for fluid removal

Timeline

• Start date: 2021-04-09
• Primary completion: 2023-09-13
• Completion: 2023-09-13
• First posted: 2020-11-25
• Last updated: 2024-02-20

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study