Clinical trial NCT04644731: Ultrafiltration Therapy Registry Using Aquadex (ULTRA-Peds)
Official title: ULTRA-Peds: A Multicenter Data Registry for Outcomes for Pediatric Volume Overload
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Fluid Overload
Lead sponsor: Nuwellis, Inc.
Sponsor class: INDUSTRY
Collaborators: name: AKI Critical Care Research Foundation
First posted: 2020-11-25
Enrollment: 97
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients who require fluid removal with the Aquadex™ System per local standard of care

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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: Treatment Survival
timeFrame: Through completion of a treatment course, up to 3 months
measure: Survival at ICU discharge
timeFrame: Through completion of a treatment course in the ICU, up to 1 month
measure: Change in Kidney Function
timeFrame: Change eGFR and renal labs from initiation to completion of treatment, up to 3 months
measure: Hemodynamic stability at initiation of UF therapy
timeFrame: From the time of index procedure is initiated up to 60 minutes after initiation
measure: Hemodynamic stability during treatment course
timeFrame: Through completion of a treatment course, up to 3 months
measure: Change % fluid overload during treatment course
timeFrame: Through completion of a treatment course, up to 3 months
measure: Length of Stay in ICU
timeFrame: The time from admission to ICU through discharge from ICU, usually 1 month
measure: Change in PRISM III Score
timeFrame: 2 hours before ICU admission through the first 4 hours after ICU discharge
measure: Aquadex related adverse events
timeFrame: Through completion of a treatment course, up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's of Alabama Hospital
state: Alabama
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital Stanford
state: California
city: Hollywood
country: United States
facility: Joe DiMaggio Children's Hospital
state: Florida
city: Indianapolis
country: United States
facility: Riley Children's Hospital
state: Indiana
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Memphis
country: United States
facility: Le Bonheur Children's Hospital
state: Tennessee
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: AKI Critical Care Research Foundation
name: Stuart Goldstein, MD
role: STUDY_CHAIR
References: