Improving care for hospitalized patients with acute kidney injury
Caring for OutPatiEnts After Acute Kidney Injury (COPE-AKI) Trial
This study is testing whether a new approach to care, which includes extra support from doctors, nurses, and pharmacists, can help hospitalized patients with acute kidney injury have more days at home after leaving the hospital.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2145 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 9 sites (Birmingham, Alabama and 8 other locations) |
| Trial ID | NCT05805709 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with Stage 2 or 3 acute kidney injury who show evidence of persistent kidney issues.
Not a fit: Patients with end-stage kidney disease, those requiring chronic dialysis, or those with specific acute kidney injury causes may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to fewer hospital days and better overall health outcomes for patients with acute kidney injury.
How similar studies have performed: Other studies have shown promise with multimodal interventions in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Birmingham, Alabama and 8 other locations
- 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)
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
- Nashville VA Medical Center — Nashville, Tennessee, United States (Recruiting)
- Vanderbilt University — Nashville, Tennessee, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.