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

Description

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.

Conditions

Acute Kidney Injury

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Study Overview

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Study Details

Study overview

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.

Caring for OutPatiEnts After Acute Kidney Injury (COPE-AKI) Trial

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

Condition
Acute Kidney Injury
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35233

New Haven

Yale University, New Haven, Connecticut, United States, 06510

Baltimore

University of Maryland, Baltimore, Maryland, United States, 21201

Baltimore

Johns Hopkins University, Baltimore, Maryland, United States, 21287

Cleveland

MetroHealth, Cleveland, Ohio, United States, 44109

Cleveland

Cleveland Clinic Foundation, Cleveland, Ohio, United States, 44195

Nashville

Vanderbilt University, Nashville, Tennessee, United States, 37232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Aged ≥ 18 years
  • 2. 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)
  • 1. AKI due to primary glomerulonephritis, renal vasculitis, or thrombotic microangiopathy
  • 2. Diagnosis of end-stage kidney disease (ESKD) at the time of admission, defined as:
  • 1. Baseline estimated glomerular filtration rate (eGFR) \<15 mL/min/1.73m2
  • 2. Previous kidney transplant recipient
  • 3. On chronic dialysis
  • 3. Acute urinary obstruction with rapid kidney function improvement following relief of obstruction
  • 4. Index hospitalization involving nephrectomy
  • 5. Index hospitalization involving solid organ transplant or stem cell/bone marrow transplant
  • 6. Continued dialysis dependence at time of discharge
  • 7. Previous (within 6 months) or new referral to a nephrologist for care specifically for:
  • 1. Previous or new diagnosis of glomerulonephritis
  • 2. Primary electrolyte imbalance disorders unrelated to AKI (e.g., syndrome of inappropriate antidiuretic hormone secretion, Bartter syndrome)
  • 3. Active treatment for acute interstitial nephritis
  • 8. Non-kidney end-organ failure:
  • 1. Class IV congestive heart failure
  • 2. Decompensated cirrhosis with Model For End-Stage Liver Disease (MELD) \> 30 or those with a diagnosis of hepatorenal syndrome by the clinical teams
  • 3. End-stage pulmonary disease (advanced stage chronic obstructive pulmonary disease, interstitial lung disease, cystic fibrosis, pulmonary hypertension)
  • 9. Metastatic malignancy or malignancy requiring active treatment (chemotherapy, immunotherapy), such as multiple myeloma
  • 10. Primary goal of care is palliation: life expectancy \<6 months
  • 11. Pregnancy
  • 12. Vulnerable populations
  • 1. Persons incarcerated
  • 2. Persons institutionalized
  • 13. Inability to provide informed consent
  • 14. Concurrent enrollment in a separate greater than minimal risk interventional trial
  • 15. Inability to participate in either in-person or remote visits
  • 16. Discharge to long-term acute care facility or other hospital-based location

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Pittsburgh,

Kaleab Abebe, PhD, PRINCIPAL_INVESTIGATOR, Univerisity of Pittsburgh

Linda Fried, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Paul Palevsky, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Sandy Kane-Gill, PharmD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

2027-03-05