Ultrafiltration Therapy Registry Using Aquadex (ULTRA-Peds)

Study Overview
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Brief Summary
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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
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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)

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

Conditions
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Fluid Overload

Intervention / Treatment
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* Device: Aquadex™ System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Unable or unwilling to provide informed consent Unable or unwilling to comply with study requirements

Ages Eligible for Study
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Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pediatric patients who require fluid removal<br>Pediatric patients who require fluid removal with the Aquadex™ System per local standard of care | Device: Aquadex™ System<br>* Ultrafiltration for fluid removal<br>|

What is the study measuring?
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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 |