Improving care for hospitalized patients with acute kidney injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The COPE-AKI trial is a randomized, pragmatic trial that compares a multimodal intervention to usual care for hospitalized patients with acute kidney injury (AKI). The intervention includes physician oversight, a nurse navigator for education and care coordination, and pharmacist-led medication reconciliation. The primary goal is to increase hospital-free days over a 90-day follow-up period, while secondary outcomes include rates of major adverse kidney events and improvements in patient-reported outcomes. Participants will be randomly assigned to either the intervention or usual care group using a web-based randomization system.

Why it matters

Who can join: the full rules

Inclusion 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)

Exclusion Criteria:

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

    a. Impaired cognition as demonstrated by the Brief Confusion Assessment Method (bCAM)
14. Concurrent enrollment in a separate greater than minimal risk interventional trial
15. Inability to participate in either in-person or remote visits

    a. Inability to participate as determined by the research team at time of discharge based on disposition (vs uniform decision across site about exclusion based on SNF)
16. Discharge to long-term acute care facility or other hospital-based location

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Yale University
  New Haven, Connecticut, United States Recruiting
• Cleveland Clinic Weston Hospital
  Weston, Florida, United States Recruiting
• University of Maryland
  Baltimore, Maryland, United States Recruiting
• Johns Hopkins University
  Baltimore, Maryland, United States Recruiting
• MetroHealth
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Kaleab Abebe, PhD — Univerisity of Pittsburgh
• Study coordinator: Susan J Copelli, MSHI
• Email: sju1@pitt.edu
• Phone: 412-245-0803

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.