Fluid OverloadULTRA-PedsNCT04644731
Ultrafiltration Therapy Registry Using Aquadex (ULTRA-Peds)
An observational study of Fluid Overload, run by Nuwellis, Inc. at 7 sites in United States.
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.… Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Fluid Overload
- What is being tested?
- Aquadex™ System
- Type of treatment
- Medical device
- How many people
- 97 participants
- Where
- 7 sitesUnited States
- Study dates
- 9 Apr 2021to 13 Sep 2023
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients who require fluid removal with the Aquadex™ System per local standard of care
Who may be able to join
- 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.
- For enrollment in retrospective data collection:
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- 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.
Who cannot join
- Unable or unwilling to provide informed consent
- Unable or unwilling to comply with study requirements
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Children's of Alabama Hospital
Birmingham, Alabama, 35233
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
Riley Children's Hospital
Indianapolis, Indiana, 46202
Le Bonheur Children's Hospital
Memphis, Tennessee, 38105
Lucile Packard Children's Hospital Stanford
Palo Alto, California, 94304
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: 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.
Read the 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
- Being tested
- Aquadex™ System
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquadex™ SystemDevice
Ultrafiltration for fluid removal
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients who require fluid removal | Pediatric patients who require fluid removal with the Aquadex™ System per local standard of care Receives: Device: Aquadex™ System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Survival
Patient survive treatment course
Measured: Through completion of a treatment course, up to 3 months
Survival at ICU discharge
% of ICU patients survive treatment in ICU
Measured: Through completion of a treatment course in the ICU, up to 1 month
Change in Kidney Function
Assessment of Kidney function
Measured: 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)
Measured: From the time of index procedure is initiated up to 60 minutes after initiation
Hemodynamic stability during treatment course
Need for vasoactive medication
Measured: 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
Measured: Through completion of a treatment course, up to 3 months
Length of Stay in ICU
Time of admission to ICU to discharge
Measured: 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
Measured: 2 hours before ICU admission through the first 4 hours after ICU discharge
Aquadex related adverse events
Aquadex related adverse events
Measured: Through completion of a treatment course, up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start9 Apr 2021
- Primary completion13 Sep 2023
- Study completion13 Sep 2023
Why it stopped: The study was stopped early only due to a business decision to pursue development of a pediatric dedicated device. This decision was not based on any efficacy or safety concerns."
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid OverloadStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 97 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Nuwellis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AKI Critical Care Research Foundation
- Responsible party
- Sponsor
- Investigators
- Stuart Goldstein, MD, Study chair, AKI Critical Care Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644731
- Sponsor's protocol ID
- CLIN07423
- Acronym
- ULTRA-Peds
- Status last verified
- Feb 2024
- First submitted
- 10 Nov 2020
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ULTRA-Peds: A Multicenter Data Registry for Outcomes for Pediatric Volume Overload
- ClinicalTrials.gov ID
- NCT04644731
- Acronym / sponsor ID
- ULTRA-Peds / CLIN07423
- Conditions
- Fluid Overload
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was stopped early only due to a business decision to pursue development of a pediatric dedicated device. This decision was not based on any efficacy or safety concerns."
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Nuwellis, Inc.Industry (pharma, biotech, devices)
- Collaborators
- AKI Critical Care Research Foundation
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 13 Sep 2023 (actual)
- Study completion
- 13 Sep 2023 (actual)
- First posted
- 25 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients who require fluid removal | – | Device: Aquadex™ SystemPediatric patients who require fluid removal with the Aquadex™ System per local standard of care |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients who require fluid removal with the Aquadex™ System per local standard of care
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (2 listed)
- Unable or unwilling to provide informed consent
- Unable or unwilling to comply with study requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aquadex™ SystemUltrafiltration for fluid removal | Device | Pediatric patients who require fluid removal |
Primary outcome
Treatment Survival
Time frame: Through completion of a treatment course, up to 3 months
Patient survive treatment course
Survival at ICU discharge
Time frame: Through completion of a treatment course in the ICU, up to 1 month
% of ICU patients survive treatment in ICU
Change in Kidney Function
Time frame: Change eGFR and renal labs from initiation to completion of treatment, up to 3 months
Assessment of Kidney function
Hemodynamic stability at initiation of UF therapy
Time frame: From the time of index procedure is initiated up to 60 minutes after initiation
Need resuscitation fluids and medications (e.g. vasoactive medication)
Hemodynamic stability during treatment course
Time frame: Through completion of a treatment course, up to 3 months
Need for vasoactive medication
Change % fluid overload during treatment course
Time frame: Through completion of a treatment course, up to 3 months
% change in weight from initiation to the end of the last Aquadex procedure
Length of Stay in ICU
Time frame: The time from admission to ICU through discharge from ICU, usually 1 month
Time of admission to ICU to discharge
Change in PRISM III Score
Time frame: 2 hours before ICU admission through the first 4 hours after ICU discharge
Physiologic variables and labs to assess mortality risk
Aquadex related adverse events
Time frame: Through completion of a treatment course, up to 3 months
Aquadex related adverse events
Results and safety
The study was stopped early (reason given: The study was stopped early only due to a business decision to pursue development of a pediatric dedicated device. This decision was not based on any efficacy or safety concerns."). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Fluid Overload
Not yet recruiting
Bioimpedance and Multiparametric Ultrasound-Guided Fluid Management After Kidney Transplantation
Kidney Transplantation, Delayed Graft Function
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
Not yet recruitingPhase 4
Capital Offload-Shock
Hypervolemia, Cardiogenic Shock
Recruiting
Diuretic Tuner Clinical Decision Support
Edema, Hypervolemia
Enrolling by invitationObservational study
Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0
Acute Kidney Injury, Fluid Overload
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart Goldstein, MD study chair
AKI Critical Care Research Foundation
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fluid Overload, run by Nuwellis, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was stopped early only due to a business decision to pursue development of a pediatric dedicated device. This decision was not based on any efficacy or safety concerns."). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Survival (time frame: Through completion of a treatment course, up to 3 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.