RECRUITING

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

Conditions

Acute Kidney Injury process of care acute renal failure kidney failure kidney damage pragmatic nurse navigator pharmacist

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-09-05

Study Completion:2027-03-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05805709

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Beata Pasek, EdD

CONTACT

412-246-6931

bbp10@pitt.edu

Kaleab Abebe, PhD

CONTACT

kza3@pitt.edu

Principal Investigator

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 Locations (Sites)

University of Alabama at Birmingham

Birmingham, Alabama, 35233

United States

Yale University

New Haven, Connecticut, 06510

United States

University of Maryland

Baltimore, Maryland, 21201

United States

Johns Hopkins University

Baltimore, Maryland, 21287

United States

MetroHealth

Cleveland, Ohio, 44109

United States

Cleveland Clinic Foundation

Cleveland, Ohio, 44195

United States

Vanderbilt University

Nashville, Tennessee, 37232

United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-05

Study Completion Date2027-03-05

Study Record Updates

Study Start Date2023-09-05

Study Completion Date2027-03-05

Terms related to this study

Keywords Provided by Researchers

acute kidney injury
process of care
acute renal failure
kidney failure
kidney damage
pragmatic
nurse navigator
pharmacist

Additional Relevant MeSH Terms

Acute Kidney Injury