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Trial · NCT02771977

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPercentage of Patients With Progression of AKI OR Dialysis OR Death14 days from Randomization
Progression of AKI is defined by an increase in KDIGO creatinine stage from time of randomization to the present. Dialysis is defined by the receipt of hemodialysis, continuous renal replacement therapy or peritoneal dialysis. Isolated ultrafiltration treatments will not be included. Mortality will be determined from hospital records.
SecondaryPercentage of Patients for Whom Any One of the Targeted Medications is DiscontinuedAssessed within 24 hours from randomization
The Percentage of patients for whom the targeted agent was discontinued within 24 hours from randomization. For individuals with active orders for more than one targeted agent, cessation of any will be adequate to meet this endpoint.
Secondary14- Day Mortality RateAssessed from date of randomization to date of death from any cause, within 14 days of randomizationPercentage of patients who expire within 14 days of randomization
SecondaryInpatient Mortality RateAssessed from point of randomization to the date of death from any cause during the end of current index hospitalization, up to 365 daysPercentage of patients who expire during index hospitalization.
SecondaryPercentage of Patients Who Receive Dialysis Within 14 Days of RandomizationAssessed from point of randomization to date of first documented dialysis order, within 14 days of randomizationReceipt of hemodialysis, continuous renal replacement, or peritoneal dialysis within 14 days of randomization
SecondaryPercentage of Patients on Inpatient DialysisAssessed from point of randomization to the date of first documented dialysis order during index hospitalization, up to 365 daysReceipt of hemodialysis, continuous renal replacement, or peritoneal dialysis during index hospitalization
SecondaryPercentage of Patients Discharged on DialysisAssessed at the point of discharge from index hospitalization, up to 365 days post randomizationActive orders for dialysis at the point of discharge from the index hospitalization
SecondaryPercentage of Patients With AKI Progression From Stage 1 to Stage 2Assessed from date of randomization to date of documented AKI progression, within 14 days of randomizationProgression to stage 2 AKI, represented by a doubling of baseline creatinine levels.
SecondaryPercentage of Patients With AKI Progression From Stage 2 to Stage 3Assessed from date of randomization to date of documented AKI progression, within 14 days of randomizationProgression to stage 3 AKI, represented by a tripling of baseline creatinine levels.
SecondaryAKI DurationAssessed from the point of randomization to the point of AKI cessation during index hospitalization, up to 365 daysTime in hours between AKI onset and AKI cessation during index hospitalization
SecondaryReadmission RateWithin 30 days of index hospitalization dischargeNumber of readmissions within 30 days of discharge from index hospitalization
SecondaryIndex Hospitalization CostAssessed from point of randomization to the date of discharge from index hospitalization, up to 365 days post randomizationTotal cost of index hospitalization
SecondaryPercentage of AKI "Best Practices" Achieved Per Subject During Index HospitalizationAssessed from 24 hours from randomization up to discharge of index hospitalization
Best practices assessed include: Avoidance of nephrotoxins (cessation of order or absence of de novo order of IV constrast agent, aminoglycoside, NSAID, or ACE inhibitor within 24 hours of randomization), fluid administration (administration of fluids within 24 hours of randomization), urinalysis order (with or without microscopy within 24 hours of randomization), documentation of AKI (by ICD-9 and ICD-10 codes during index hospitalization), monitoring of creatinine (at least one serum creatinine measurement occurring within 36 hours of randomization), documentation of urine output (within 24 hours of randomization), renal consult order during index hospitalization. Each metric above is binary. Outcome is reported as a composite best practice outcome representing the proportion of best practices achieved per subject.
SecondaryPercentage of Subjects With Chart Documentation of AKIAssessed from time of randomization through to date of index hospitalization discharge, up to 365 days post randomizationPercentage of subjects with chart documentation of AKI by post-discharge ICD-10 codes and by chart adjudication

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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