NCT03556293: IMPROVE-AKI

IMPROVE AKI Cluster-Randomized Trial

Completed NA Results posted Last updated 18 March 2025

What this trial tests

NA trial testing AKI Prevention Toolkit in Acute Kidney Injury in 10,252 participants. Completed in 31 January 2023.

Timeline

1 September 2019

Primary endpoint
30 November 2022

31 January 2023

Quick facts

Lead sponsor	Dartmouth-Hitchcock Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	none
Primary purpose	prevention
Enrollment	10,252
Start date	1 September 2019
Primary completion	30 November 2022
Estimated completion	31 January 2023
Sites	2 locations across United States

Drugs / interventions tested

• AKI Prevention Toolkit
• Technical Assistance (TA)
• Virtual Learning Collaborative (VLC)
• Automated Surveillance Reporting (ASR)

Conditions studied

• Acute Kidney Injury — all drugs for Acute Kidney Injury →

Sponsor

Dartmouth-Hitchcock Medical Center

Who can join

Eligibility, any sex, with Acute Kidney Injury. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Acute Kidney Injury Primary · within 48-hours of the procedure or within 7-days for in-patients, or onset of dialysis within 7-days

Number of Participants with Acute Kidney Injury

Group	Value	95% CI
Technical Assistance (No ASR)	110
Virtual Learning Collaborative (No ASR)	190
Technical Assistance With ASR	122
Virtual Learning Collaborative With ASR	88

Adverse events — posted to ClinicalTrials.gov

Time frame: 18-months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Technical Assistance (No ASR)

Serious: 213/830 (26%)

Deaths: 2/830

Virtual Learning Collaborative (No ASR)

Serious: 355/1496 (24%)

Deaths: 3/1496

Technical Assistance With ASR

Serious: 331/1073 (31%)

Deaths: 1/1073

Virtual Learning Collaborative With ASR

Serious: 234/1118 (21%)

Deaths: 2/1118

Serious adverse events (5 terms)

Reaction	System	Technical Assistance (No A…	Virtual Learning Collabora…	Technical Assistance With …	Virtual Learning Collabora…
New Heart Failure	Cardiac disorders	—	—	—	—
Myocardial Infarction	Cardiac disorders	—	—	—	—
Bleeding	Blood and lymphatic system disorders	—	—	—	—
Stroke	Vascular disorders	—	—	—	—
New Onset Dialysis	Renal and urinary disorders	—	—	—	—

Most-reported serious reactions: New Heart Failure, Myocardial Infarction, Bleeding, Stroke, New Onset Dialysis.

Data from ClinicalTrials.gov NCT03556293 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Management of Patients With Kidney Disease in Need of Cardiovascular Catheterization: A Scientific Workshop Cosponsored by the National Kidney Foundation and the Society for Cardiovascular Angiography and Interventions.
   Prasad A, Palevsky PM, Bansal S, Chertow GM, et al · · 2022 · cited 7× · PMID 39132354 · DOI 10.1016/j.jscai.2022.100445
2. Team-Based Coaching Intervention to Improve Contrast-Associated Acute Kidney Injury: A Cluster-Randomized Trial.
   Brown JR, Solomon R, Stabler ME, Davis S, et al · · 2023 · cited 7× · PMID 36787125 · DOI 10.2215/cjn.0000000000000067
3. Sustained Improvements After Intervention to Prevent Contrast-Associated Acute Kidney Injury: A Randomized Controlled Trial.
   Matheny ME, Carpenter-Song E, Ricket IM, Solomon RJ, et al · · 2025 · cited 3× · PMID 40371586 · DOI 10.1161/jaha.124.038920