N/A N=4,003 Randomized Triple-blind Health Services Research

Personalized Recommendations for Acute Kidney Injury (AKI) Care

Acute Kidney Injury

Bottom Line

View on ClinicalTrials.gov: NCT04040296 ↗

Enrolled (actual)

4,003

Serious AEs

0.0%

Results posted

Jul 2025

Primary outcome: Primary: Composite Outcome Showing the Percentage of Participants With Any One of the Following: Progression of AKI, Inpatient Dialysis, or Inpatient Death — 369; 395 Participants — p=0.28

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Kidney Action Team Recommendations (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Yale University
Primary completion: Feb 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Composite Outcome Showing the Percentage of Participants With Any One of the Following: Progression of AKI, Inpatient Dialysis, or Inpatient Death	369; 395	0.28
SECONDARY Percentage of Recommendations Implemented by the Primary Care Team	1766; 2459; 7269; 7270	<.001 sig
SECONDARY Percentage of Patients With Progression of Acute Kidney Injury	261; 270	.65
SECONDARY Percentage of Patients Who Receive Inpatient Dialysis	30; 31	.89
SECONDARY Percentage of Inpatient Mortality	185; 191	.72
SECONDARY Percent of Patients Who Receive a Kidney Consult Within 14 Days	284; 321	.31
SECONDARY Percent of Patients Who Are Discharged to Hospice Care 14 Days	106; 87	.17

Summary

This is a randomized clinical trial of a "Kidney Action Team", which will provide timely, personalized recommendations for the diagnosis and initial treatment of hospitalized patients with Acute Kidney Injury (AKI).

Eligibility Criteria

Inclusion Criteria

Adults ≥ 18 years admitted to a participating hospital (six hospitals in the Yale New Haven Health system and two hospitals of the John Hopkins University Health system)
Stage 1 Acute Kidney Injury as defined by KDIGO creatinine criteria:
0.3 mg/dl increase in inpatient serum creatine over 48 hours OR
50% relative increase in inpatient serum creatinine over 168 hours

Exclusion Criteria

Admission to hospice service or comfort measures only order
Recipient of a solid organ transplant
Immediate dialytic indication determined by the following:
serum K >/= 7
arterial pH 150 mg/dL
acute ingestion of dialyzable toxins
refractory volume overload

Patients who meet any of these critical values will not be enrolled in the trial and the Kidney Action Team will directly notify the treating team.

Pre-existing CKD stage V or End Stage Kidney Disease
Initial hospital creatinine > 4.0 mg/dl
Patients who have been seen by nephrology or already have a nephrology consult
Status post-nephrectomy (partial or radical) during index admission

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04040296). 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.