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NCT04608149 · ClinicalTrials.gov registry record
Prospective, Multi-center, Single-arm, Observational Study. US FDA 522 Pediatric Post Market Surveillance Study.
A clinical trial of Acute Kidney Injury and Fluid Overload, sponsored by Medtronic - MITG.
- Active
- Registry status
- 36
- Enrollment target
- 6
- Study locations
NCT04608149: Active study of Acute Kidney Injury and Fluid Overload, sponsored by Medtronic - MITG.
NCT04608149 is a study of Acute Kidney Injury and Fluid Overload that is active but no longer recruiting, run by Medtronic - MITG. The registered enrollment target is 36 participants, below the 2,330-participant average among 74 other Acute Kidney Injury trials with a reported enrollment target (98% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04608149, a study of Acute Kidney Injury and Fluid Overload, is active but no longer recruiting, sponsored by Medtronic - MITG.
- ACTIVE NOT RECRUITING
- Registry status
- 36 participants
- Enrollment target
- 6
- Study locations
Study Summary
The post market surveillance study will employ a prospective, multi-center, single-arm, observational design to capture data on children who undergo CRRT using the Carpediem™ system. Participating clinicians will manage subjects in accordance to their local standard of care practices and decisions on initiating, modifying or discontinuing CRRT are up to the local investigative team's prescription. A minimum of 10 centers in the United States, that have been trained on the use of the Carpediem™ system, will be invited to participate in the study. After obtaining institutional review board approval and written informed consent from a parent or legally authorized representative (LAR), data from all subjects treated with the Carpediem™ system will be included in the study. A minimum of 35 subjects will be enrolled and sites may be asked to screen and enroll patients for the study for up to 36 months. Status of subjects discharged from hospital will be collected at 30- and-90 days following hospital discharge by phone interviews in accordance to local standard of care practices, review of in-hospital records or in-clinic visit, as available.
Primary Outcome
Evaluation subject survival at CRRT discontinuation
Conditions Studied
Interventions
- DEVICE Carpediem System
Study Locations (6)
Iowa
- University of Iowa Healthcare - Iowa City
Minnesota
- Mayo Clinic - Rochester
New York
- Golisano Children's Hospital - Rochester
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Texas
- Texas Children's Hospital - Houston
Washington
- Seattle Children's - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2021-01-20 |
| Est. Completion | 2026-04 |
What the registry record for NCT04608149 still lists
NCT04608149 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 2,330-participant average among 74 other Acute Kidney Injury trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Acute Kidney Injury appearing as the primary indexed condition, and to 1 intervention - of which Carpediem System is the first listed.
NCT04608149 lists 6 locations in 6 states (Iowa, Minnesota, New York).
Frequently Asked Questions
What is clinical trial NCT04608149 about?
NCT04608149 is a clinical study titled "Prospective, Multi-center, Single-arm, Observational Study. US FDA 522 Pediatric Post Market Surveillance Study.". The post market surveillance study will employ a prospective, multi-center, single-arm, observational design to capture data on children who undergo CRRT using the Carpediem™ system. Participating clinicians will manage subjects in accordance to their local standard of care practices and decisions o...
What is the current status of trial NCT04608149?
This trial is currently active not recruiting. The enrollment target is 36 participants. The study started on 2021-01-20. Estimated completion is 2026-04.
What conditions does trial NCT04608149 study?
This clinical trial studies the following conditions: Acute Kidney Injury, Fluid Overload.
What interventions are being tested in trial NCT04608149?
The interventions under investigation include: Carpediem System (DEVICE).
Who is sponsoring clinical trial NCT04608149?
This trial is sponsored by Medtronic - MITG, which has 119 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04608149 being conducted?
This trial has 6 study locations across Iowa, Minnesota, New York, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04608149's enrollment target sits among peer trials
36 61st of 74 higher than 14 of 74 other Acute Kidney Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Kidney Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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