New care program aims to keep kidney patients out of the hospital
NCT ID NCT05805709
First seen Jun 26, 2026 · Last updated Jul 07, 2026 · Updated 3 times
Summary
This study tests whether a special follow-up program led by nurses and kidney specialists helps people recover better after a serious kidney injury. About 2,145 adults who had moderate to severe kidney injury in the hospital will be randomly assigned to either the program or usual care. The program includes discharge planning, education, and close monitoring to reduce hospital readmissions and support kidney recovery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- nurse-led care program with specialist supervision
- What this could lead to
- If successful, this could establish a standard follow-up care model that helps kidney injury patients recover faster and avoid repeat hospital stays.
- What could go wrong
- This is a pragmatic trial testing a care coordination approach, not a new drug or therapy. The intervention may not significantly improve outcomes over usual care, and results may vary across hospitals.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 2,145 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2023
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
9 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cleveland Clinic Foundation
RECRUITINGCleveland, Ohio, 44195, United States
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Cleveland Clinic Weston Hospital
RECRUITINGWeston, Florida, 33331, United States
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Johns Hopkins University
RECRUITINGBaltimore, Maryland, 21287, United States
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MetroHealth
RECRUITINGCleveland, Ohio, 44109, United States
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Nashville VA Medical Center
RECRUITINGNashville, Tennessee, 37212-2637, United States
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University of Alabama at Birmingham
RECRUITINGBirmingham, Alabama, 35233, United States
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University of Maryland
RECRUITINGBaltimore, Maryland, 21201, United States
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Vanderbilt University
RECRUITINGNashville, Tennessee, 37232, United States
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Yale University
RECRUITINGNew Haven, Connecticut, 06510, United States
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Other studies related to the condition(s) this trial covers.
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- Heart attack delay may signal kidney risk after angioplasty
- ICU kidney injury: does the pattern predict lasting damage?
- Can a kidney ultrasound scan warn of kidney damage after heart bypass surgery?
- Two blood tests may separate real kidney harm from a false alarm
- Can watching kidney oxygen during liver surgery keep kidneys safe?