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Trial · NCT04633889

Registered outcomes11

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

ListOutcomeTime frameDescription
PrimaryAcute Kidney Injury7 days
Composite outcome that includes any of the following: 1. Urine output \<0.5 ml/kg/h for ≥6 consecutive hours within the first 48h or until the Foley catheter is removed, whichever occurs first 2. Increase in serum creatinine ≥0.3 mg/dl within the first 48h 3. Increase in serum creatinine ≥50% within 7 days 4. Receipt of renal replacement therapy within 7 days
SecondaryRenal Tubular Injury3 daysUrine KIM-1 standardized to urine creatinine
SecondaryNumber of Participants With Major Adverse Kidney Events7 daysDefined as an increase in serum creatinine ≥100%, receipt of renal replacement therapy, or death within 7 days
SecondaryNumber of Participants With Postoperative Myocardial Injury2 daysDefined as postoperative hs-cTnI concentration ≥ the 90th percentile of the cohort on either postoperative day 1 or 2.
SecondaryNumber of Participants With Atrial Fibrillation or Atrial Flutter7 daysDefined as new onset postoperative atrial fibrillation or atrial flutter (patients with atrial fibrillation or atrial flutter at baseline will be excluded)
SecondaryNumber of Participants With Prolonged Mechanical Ventilation24 hoursDefined as a requirement for mechanical ventilation \>24h postoperatively
SecondaryTime to Liberation From Vasoactive Medications7 daysNumber of hours from time of incision to liberation from all IV vasoactive medications
SecondaryNumber of Participants With Sepsis7 days
Defined as a life-threatening organ dysfunction caused by a dysregulated host response to infection. Organ dysfunction is defined as an acute increase in the total SOFA score ≥2 points consequent to the infection.
SecondaryVentilator-free Days28 days28 minus the number of days ventilated. Patients who die within 28 days will be assigned 0 ventilator-free days.
SecondaryICU-free Days28 days28 minus the number of days in the ICU. Patients who die within 28 days will be assigned 0 ICU-free days.
SecondaryHospital-free Days28 days28 minus the number of days hospitalized. Patients who die within 28 days will be assigned 0 hospital-free days.

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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