N/A
N=10,252
IMPROVE AKI Cluster-Randomized Trial
Acute Kidney Injury
Bottom Line
View on ClinicalTrials.gov: NCT03556293 ↗Enrolled (actual)
10,252
Serious AEs
25.1%
Results posted
Mar 2025
Primary outcome: Primary: Acute Kidney Injury — 110; 190; 122; 88 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AKI Prevention Toolkit (Behavioral); Technical Assistance (TA) (Behavioral); Virtual Learning Collaborative (VLC) (Behavioral); Automated Surveillance Reporting (ASR) (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acute Kidney Injury |
110; 190; 122; 88 | — |
Summary
When a person has an imaging procedure that uses radio-contrast dye, there is a possibility of damage to that person's kidneys, which could result in being on dialysis or early death. The investigators are testing novel coaching and automated tools to help healthcare teams apply approaches that have been shown to prevent damage to kidneys during a cardiac catheterization procedure. The results of our study will help inform health care leaders on how to implement low-cost preventive strategies through team-based coaching and surveillance reporting for kidney injury and other patient safety priorities to every hospital in the United States.
Eligibility Criteria
Inclusion Criteria
- VA Site Inclusion Criteria: All VA medical centers with a cardiac catheterization laboratory are eligible, and all catheterization operators at a site are included.
- Patient Inclusion Criteria: Among these sites, only patients aged 18 or greater with pre-existing CKD who undergo diagnostic coronary angiography or percutaneous coronary intervention (PCI or angioplasty) will be enrolled in the trial. CKD will be determined by a pre-existing CKD diagnosis in the VA medical record, or by two or more estimated glomerular filtration rates <60 (ml/min/1.73 m2) at least 90-days apart prior to presentation.
Exclusion Criteria
- Patient Exclusion Criteria: Patients with a history of dialysis (hemodialysis, peritoneal dialysis), under the age of 18, or no evidence of pre-existing CKD will be excluded. Cardiac catheterization (also referred to as coronary angiography) is defined as a procedure in which a catheter is inserted into the femoral or radial artery and is threaded to the cardiac vasculature where radio-contrast dye is administered and a series of x-rays obtained in order to visualize the coronary arterial anatomy. PCI is when a clinical intervention is then performed to address any treatable pathology that is found.
Data sourced from ClinicalTrials.gov (NCT03556293). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.