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NCT05805709 · ClinicalTrials.gov registry record · NA
A Patient-centered Trial of a Process-of-care Intervention in Hospitalized AKI Patients: the COPE-AKI Trial
A NA study of Acute Kidney Injury, sponsored by University of Pittsburgh.
- Recruiting
- Registry status
- NA
- Development phase
- 2,145
- Enrollment target
- 9
- Study locations
NCT05805709: Recruiting NA study of Acute Kidney Injury, sponsored by University of Pittsburgh.
NCT05805709 is a NA study of Acute Kidney Injury that is actively recruiting participants, run by University of Pittsburgh. The registered enrollment target is 2,145 participants, roughly in line with the 2,302-participant average among 74 other Acute Kidney Injury trials with a reported enrollment target. The trial reports 9 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05805709, a NA study of Acute Kidney Injury, is actively recruiting participants, sponsored by University of Pittsburgh.
- RECRUITING
- Registry status
- NA
- Development phase
- 2,145 participants
- Enrollment target
- 9
- Study locations
Study Summary
The COPE-AKI study is a randomized, pragmatic, parallel-arm trial comparing a multimodal intervention to usual care on hospital-free days through 90 days of study follow up. The primary study hypothesis is that patients randomized to the intervention will have increased odds of more hospital-free days through 90 days (primary clinical) compared to those randomized to usual care. Key secondary hypotheses will investigate the impact of the intervention on rates of major adverse kidney events, rates of recurrent AKI, and changes in patient-reported outcomes. Participants (N=2145) will be allocated 1:1 to the intervention or usual care using a web-based system to maintain allocation concealment using stratified randomization with randomly permuted blocks. Randomization will be stratified by clinical site.
Primary Outcome
Hospital-free days through day 90 defined as 90 minus the number of calendar days in the hospital as either an inpatient or on observation status.
Conditions Studied
Interventions
- OTHER Patient Education
- OTHER Study Physician/Advance Practice Provider
- OTHER Nurse Navigator
- OTHER Pharmacist
Study Locations (9)
Maryland
- University of Maryland - Baltimore
- Johns Hopkins University - Baltimore
Ohio
- MetroHealth - Cleveland
- Cleveland Clinic Foundation - Cleveland
Tennessee
- Nashville VA Medical Center - Nashville
- Vanderbilt University - Nashville
Alabama
- University of Alabama at Birmingham - Birmingham
Connecticut
- Yale University - New Haven
Florida
- Cleveland Clinic Weston Hospital - Weston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,145 participants |
| Start Date | 2023-09-05 |
| Est. Completion | 2027-03-05 |
| Phase | NA |
What NCT05805709 shows while recruiting
NCT05805709 is an interventional study that assigns participants to a tested intervention. Its 2,145 participants enrollment target places it among the larger protocols in the corpus, roughly in line with the 2,302-participant average among 74 other Acute Kidney Injury trials with a reported enrollment target.
The record links to 1 condition, with Acute Kidney Injury appearing as the primary indexed condition, and to 4 interventions - of which Patient Education is the first listed.
NCT05805709 lists 9 locations in 6 states (Maryland, Ohio, Tennessee).
Frequently Asked Questions
What is clinical trial NCT05805709 about?
NCT05805709 is a clinical study titled "A Patient-centered Trial of a Process-of-care Intervention in Hospitalized AKI Patients: the COPE-AKI Trial". The COPE-AKI study is a randomized, pragmatic, parallel-arm trial comparing a multimodal intervention to usual care on hospital-free days through 90 days of study follow up. The primary study hypothesis is that patients randomized to the intervention will have increased odds of more hospital-free da...
What is the current status of trial NCT05805709?
This trial is currently recruiting. It is a NA study. The enrollment target is 2,145 participants. The study started on 2023-09-05. Estimated completion is 2027-03-05.
What conditions does trial NCT05805709 study?
This clinical trial studies the following conditions: Acute Kidney Injury.
What interventions are being tested in trial NCT05805709?
The interventions under investigation include: Patient Education (OTHER), Study Physician/Advance Practice Provider (OTHER), Nurse Navigator (OTHER), Pharmacist (OTHER).
Who is sponsoring clinical trial NCT05805709?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05805709 being conducted?
This trial has 9 study locations across Alabama, Connecticut, Florida, Maryland, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05805709's enrollment target sits among peer trials
2,145 8th of 74 higher than 67 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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