A Patient-centered Trial of a Process-of-care Intervention in Hospitalized AKI Patients: the COPE-AKI Trial

Recruiting now · Not applicable

Conditions studied: Acute Kidney Injury

In brief

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.

Key facts

Study ID: NCT05805709
Run by: University of Pittsburgh
People needed: 2145
Starts: 2023-09-05
Expected to finish: 2028-11-30
Last updated by the study team: 2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Aged ≥ 18 years
Kidney Disease Improving Global Outcomes (KDIGO) Stage 2/3 AKI with evidence of persistent AKI (defined as meeting Stage 2+ AKI for 2 consecutive days with serum creatinine concentration measurements >12 hours apart)

You may not qualify if…

AKI due to primary glomerulonephritis, renal vasculitis, or thrombotic microangiopathy
Diagnosis of end-stage kidney disease (ESKD) at the time of admission, defined as:
Baseline estimated glomerular filtration rate (eGFR) <15 mL/min/1.73m2
Previous kidney transplant recipient
On chronic dialysis
Acute urinary obstruction with rapid kidney function improvement following relief of obstruction
Index hospitalization involving nephrectomy
Index hospitalization involving solid organ transplant or stem cell/bone marrow transplant
Continued dialysis dependence at time of discharge
Previous (within 6 months) or new referral to a nephrologist for care specifically for:
Previous or new diagnosis of glomerulonephritis
Primary electrolyte imbalance disorders unrelated to AKI (e.g., syndrome of inappropriate antidiuretic hormone secretion, Bartter syndrome)
Active treatment for acute interstitial nephritis
Non-kidney end-organ failure:
Class IV congestive heart failure
Decompensated cirrhosis with Model For End-Stage Liver Disease (MELD) > 30 or those with a diagnosis of hepatorenal syndrome by the clinical teams
End-stage pulmonary disease (advanced stage chronic obstructive pulmonary disease, interstitial lung disease, cystic fibrosis, pulmonary hypertension)
Metastatic malignancy or malignancy requiring active treatment (chemotherapy, immunotherapy), such as multiple myeloma
Primary goal of care is palliation: life expectancy <6 months
Pregnancy
Vulnerable populations
Persons incarcerated
Persons institutionalized
Inability to provide informed consent
a. Impaired cognition as demonstrated by the Brief Confusion Assessment Method (bCAM)

Where it is running

University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
Yale University — New Haven, Connecticut, United States (enrolling)
Cleveland Clinic Weston Hospital — Weston, Florida, United States (enrolling)
University of Maryland — Baltimore, Maryland, United States (enrolling)
Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
MetroHealth — Cleveland, Ohio, United States (enrolling)
Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)
Nashville VA Medical Center — Nashville, Tennessee, United States (enrolling)
Vanderbilt University — Nashville, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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