Trial · NCT02786277
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients With Progression to a Higher Stage of AKI OR Dialysis OR Death | Within 14 days from randomization | Progression of AKI is defined as the increase in KDIGO stage from the time of randomization to the present. For patients who are discharged, we will impute 14-day creatinine using the last observation carried forward method. Dialysis is defined as the receipt of hemodialysis, continuous renal replacement therapy, or peritoneal dialysis. Isolated ultrafiltration treatments will not be included. Mortality will be determined from hospital administrative records. |
| Secondary | 14-day Mortality | Assessed from point of randomization to date of death within 14 days of randomization | Proportion of patients who expire from any cause |
| Secondary | Inpatient Mortality | Assessed from point of randomization to date of death from any cause, up to one year post-randomization | Proportion of patients who expire from any cause |
| Secondary | 14-day Dialysis | Assessed from point of randomization to date of first documented dialysis order, within 14 days of randomization | Proportion of patients who receive dialysis (hemodialysis, continuous renal replacement therapy, or peritoneal dialysis) |
| Secondary | Inpatient Dialysis | Assess from point of randomization to date of first documented dialysis order during index hospitalization, up to one year post-randomization | Proportion of patients who receive dialysis (hemodialysis, continuous renal replacement therapy, or peritoneal dialysis) |
| Secondary | Discharge on Dialysis | Assessed at point of discharge from index hospitalization, up to one year post-randomization | Assessed as active orders for dialysis at point of discharge from index hospitalization |
| Secondary | Progression to Stage 2 AKI | Assessed from the date of randomization to 14 days post randomization | Progression to Stage 2 AKI is defined as a doubling of serum creatinine between randomization and 14 days post randomization, and is considered a worsening of AKI. |
| Secondary | Progression to Stage 3 AKI | Assessed from the date of randomization to 14 days post randomization | Progression to Stage 3 AKI is defined as a tripling of serum creatinine between the date of randomization and 14 days post randomization, and is considered a worsening of AKI. |
| Secondary | Duration of AKI | Assessed from the date of randomization to the cessation of AKI during index hospitalization, up to one year | Defined as the time in hours between AKI onset and AKI cessation during index hospitalization |
| Secondary | 30 Day Readmission Rate | Assessed from discharge date of index hospitalization to 30 days post discharge date | Proportion of patients with readmission within 30 days of index hospitalization discharge |
| Secondary | Index Hospitalization Cost | Assessed from point of randomization to date of discharge from index hospitalization, up to one year | Total cost of index hospitalization |
| Secondary | Chart Documentation of AKI | Assessed from date of randomization to date of discharge from index hospitalization, up to one year | Proportion of patients with chart documentation of AKI as assessed by post-discharge ICD-10 codes |
| Secondary | Proportion of AKI "Best Practices" Achieved Per Subject During Index Hospitalization | 24 hours from randomization to discharge, up to one year post randomization | Contrast administration (de novo order of IV contrast agent within 24 hours of randomization), fluid administration (within 24 hours of randomization), aminoglycoside administration (de novo order within 24 hours of randomization), NSAID administration/cessation (de novo order or cessation of order/absence of de novo order of NSAID within 24 hours of randomization), ACE inhibitor administration/cessation, 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 within 36 hours of randomization), documentation of urine output (within 24 hours of randomization), renal consult order during index hospitalization. Each metric is binary. Outcome is reported as a composite best practice outcome representing the proportion of best practices achieved per subject. |
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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