Trial · NCT04040296
Personalized Recommendations for Acute Kidney Injury (AKI) Care
NCT04040296, Not applicable, Completed, Yale University; results first posted 2025-07-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Personalized Recommendations for Acute Kidney Injury (AKI) Care. Trials, record NCT04040296. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04040296
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Personalized Recommendations for Acute Kidney Injury (AKI) Care
- NCT number
- NCT04040296
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 4,003 participants, actual
- Lead sponsor
- Yale University
- Conditions
- Acute Kidney Injury
- Interventions
- Kidney Action Team Recommendations
- First posted
- 2019-07-31
- Last updated
- 2025-07-17
- Results first posted
- 2025-07-17
- Limitations and caveats
Timely notice, adherence and implementation of recommendations by providers was not guaranteed. Limited windows of time for enrollment may have introduced bias that affected outcomes. Given the bundled nature of the recommendations, the unique effects of a given recommendation could not be determined. Finally, though the structured recommendation form was broad and included an option for free-text recommendations, it is possible that other recommendations may have led to different effects.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Composite Outcome Showing the Percentage of Participants With Any One of the Following: Progression of AKI, Inpatient Dialysis, or Inpatient Death | 14 days post randomization or at hospital discharge, whichever comes first | Progression of AKI is defined by an increase in KDIGO creatinine stage from that present at the time of randomization. Dialysis is defined by the receipt of hemodialysis, continuous renal replacement therapy or peritoneal dialysis. Isolated ultrafiltration treatments (for the purpose of volume removal) will not be included. Mortality will be determined from hospital administrative records. The rates of the primary outcome will be compared between the study arms using the Cochrane-Mantel-Haenszel chi-square test, accounting for stratification by hospital. |
| Secondary | Percentage of Recommendations Implemented by the Primary Care Team | 24 hours after randomization | The AKI Response Team will make recommendations for all randomized patients in both the control group and the intervention group, however, recommendations will only be delivered to the primary care teams of patients in the intervention group. In this way, we can compare the percentage of recommendations that were followed by primary care teams across both groups. This outcome will be assessed by averaging the proportion of recommendations followed within 24 hours between the two study arms using the Van Elteren test to account for stratification by hospital. |
| Secondary | Percentage of Patients With Progression of Acute Kidney Injury | Assessed from time of randomization to time of AKI progression (within 14 days post randomization) | Percentage of patients who progressed from stage 1 to stage 2 or 3 or from stage 2 to stage 3 (based on changes in creatinine) within 14 days of randomization |
| Secondary | Percentage of Patients Who Receive Inpatient Dialysis | Assessed from time of randomization to time of receipt of inpatient dialysis (within 14 days post randomization) | Percentage of patients who receive hemodialysis, continuous renal replacement, or peritoneal dialysis during index hospitalization within 14 days of randomization |
| Secondary | Percentage of Inpatient Mortality | Assessed from time of randomization to date of death from any cause, within 14 days of randomization | Proportion of patients who expire within 14 days of randomization |
| Secondary | Percent of Patients Who Receive a Kidney Consult Within 14 Days | Assessed from the time of randomization to time of first kidney consult (within 14 days post-randomization) | Percent of participants receiving a kidney consult within 14 days of randomization |
| Secondary | Percent of Patients Who Are Discharged to Hospice Care 14 Days | Assessed from the time of randomization to time discharge to hospice (within 14 days post-randomization) | Percent of participants discharged to hospice within 14 days of randomization |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Composite Outcome Showing the Percentage of Participants With Any One of the Following: Progression of AKI, Inpatient Dialysis, or Inpatient Death | 14 days post randomization or at hospital discharge, whichever comes first | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Recommendations Implemented by the Primary Care Team | 24 hours after randomization | Number of recommendations | NUMBER | |
| SECONDARY | Percentage of Patients With Progression of Acute Kidney Injury | Assessed from time of randomization to time of AKI progression (within 14 days post randomization) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Patients Who Receive Inpatient Dialysis | Assessed from time of randomization to time of receipt of inpatient dialysis (within 14 days post randomization) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Inpatient Mortality | Assessed from time of randomization to date of death from any cause, within 14 days of randomization | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percent of Patients Who Receive a Kidney Consult Within 14 Days | Assessed from the time of randomization to time of first kidney consult (within 14 days post-randomization) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percent of Patients Who Are Discharged to Hospice Care 14 Days | Assessed from the time of randomization to time discharge to hospice (within 14 days post-randomization) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Composite Outcome Showing the Percentage of Participants With Any One of the Following: Progression of AKI, Inpatient Dialysis, or Inpatient Death | Usual Care | 369 | Participants | ||
| Composite Outcome Showing the Percentage of Participants With Any One of the Following: Progression of AKI, Inpatient Dialysis, or Inpatient Death | Kidney Action Team Recommendations | 395 | Participants | ||
| Percentage of Recommendations Implemented by the Primary Care Team | Usual Care | Recommendations completed | 1766 | Number of recommendations | |
| Percentage of Recommendations Implemented by the Primary Care Team | Kidney Action Team Recommendations | Recommendations completed | 2459 | Number of recommendations | |
| Percentage of Recommendations Implemented by the Primary Care Team | Usual Care | Recommendations made | 7269 | Number of recommendations | |
| Percentage of Recommendations Implemented by the Primary Care Team | Kidney Action Team Recommendations | Recommendations made | 7270 | Number of recommendations | |
| Percentage of Patients With Progression of Acute Kidney Injury | Usual Care | 261 | Participants | ||
| Percentage of Patients With Progression of Acute Kidney Injury | Kidney Action Team Recommendations | 270 | Participants | ||
| Percentage of Patients Who Receive Inpatient Dialysis | Usual Care | 30 | Participants | ||
| Percentage of Patients Who Receive Inpatient Dialysis | Kidney Action Team Recommendations | 31 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Usual Care | 2,004 | |
| Overall Study | STARTED | Kidney Action Team Recommendations | 1,999 | |
| Overall Study | COMPLETED | Usual Care | 2,004 | |
| Overall Study | COMPLETED | Kidney Action Team Recommendations | 1,999 | |
| Overall Study | NOT COMPLETED | Usual Care | 0 | |
| Overall Study | NOT COMPLETED | Kidney Action Team Recommendations | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Usual Care | 185 | 2,004 |
| Total, all-cause mortality | Kidney Action Team Recommendations | 191 | 1,999 |
| Total, other adverse events | Usual Care | 0 | 2,004 |
| Total, other adverse events | Kidney Action Team Recommendations | 0 | 1,999 |
| Total, serious adverse events | Usual Care | 0 | 2,004 |
| Total, serious adverse events | Kidney Action Team Recommendations | 0 | 1,999 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Kidney Action Team Recommendations vs Usual Care: Percentage of Patients Who Receive Inpatient Dialysis | Trial comparisons |
| Kidney Action Team Recommendations vs Usual Care: Percent of Patients Who Receive a Kidney Consult Within 14 Days | Trial comparisons |
| Kidney Action Team Recommendations vs Usual Care: Percentage of Inpatient Mortality | Trial comparisons |
| Kidney Action Team Recommendations vs Usual Care: Percentage of Patients With Progression of Acute Kidney Injury | Trial comparisons |
| Kidney Action Team Recommendations vs Usual Care: Percent of Patients Who Are Discharged to Hospice Care 14 Days | Trial comparisons |
| Kidney Action Team Recommendations vs Usual Care: Composite Outcome Showing the Percentage of Participants With Any One of the Following: Progression of AKI, Inpatient Dialysis, or Inpatient Death | Trial comparisons |
| Kidney Action Team Recommendations vs Usual Care: deaths from any cause | Trial comparisons |
| Kidney Action Team Recommendations vs Usual Care: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04040296
GET https://conductscience.org/api/trials/v1/NCT04040296/registered