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Trial · NCT03629418

Registered outcomes16

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

ListOutcomeTime frameDescription
PrimaryIncidence of acute kidney injury (AKI) within 7 days after surgeryUp to 7 days after surgeryDevelopment of AKI within 7 days after surgery is diagnosed according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria
SecondaryClassification of AKI within 7 days after surgeryUp to 7 days after surgeryDevelopment of AKI within 7 days after surgery is diagnosed according to the KDIGO criteria
SecondaryIncidence of delirium within 7 days after surgeryUp to 7 days after surgery
Development of delirium within 7 days after surgery is assessed with the Confusion Assessment Method (3D-CAM for patients without mechanical ventilation and CAM-ICU for patients with mechanical ventilation).
SecondaryDuration of mechanical ventilation after surgeryUp to 30 days after surgeryDuration of mechanical ventilation after surgery
SecondaryLength of stay in intensive care unit (ICU) after surgeryUp to 30 days after surgeryLength of stay in intensive care unit (ICU) after surgery
SecondaryLength of stay in hospital after surgeryUp to 30 days after surgeryLength of stay in hospital after surgery
SecondaryIncidence of major adverse cardiovascular events (MACEs) within 30 days after surgeryUp to 30 days after surgeryMACEs within 30 days after surgery include cardiovascular death, non-fatal cardiac arrest, acute myocardial infarction, revascularization, and stroke.
SecondaryIncidence of non-MACE complications within 30 days after surgeryUp to 30 days after surgeryNon-MACE complications within 30 days after surgery indicate new-onset medical conditions other than MACEs that produce harmful effects on patients' recovery and required therapeutic intervention.
SecondaryAll-cause 30-day mortalityAt 30 days after surgeryAll-cause 30-day mortality
Secondary2-year overall survival after surgeryUp to 2 years after surgery2-year overall survival after surgery
Secondary2-year major adverse cardiovascular event (MACE)-free survival after surgeryUp to 2 years after surgeryMACEs within 2 years after surgery include cardiovascular death, non-fatal cardiac arrest, acute myocardial infarction, revascularization, and stroke.
SecondaryCognitive function in 1- and 2-year survivorsAt the end of the 1st and 2nd years after surgeryCognitive function in 1- and 2-year survivors is assessed with the modified Telephone Interview for Cognitive Status (TICS-m, score ranges from 0 to 40, with higher score indicating better function).
SecondaryQuality of life in 1- and 2- year survivors: SF-36At the end of the 1st and 2nd years after surgery
Quality of life in 1- and 2-year survivors is assessed with the 36-Item Short Form Health Survey (SF-36). The SF-36 evaluates 8 different domains of quality of life, i.e., physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The score of each domain ranges from 0 to 100, with high score indicating better function.
OtherPain severity within 3 days after surgery: NRSUp to 3 days after surgeryPain severity is assessed with the Numeric Rating Scale (NRS, an 11-point scale where 0=no pain and 10=the worst pain) twice daily (8:00-10:00 am, 18:00-20:00 pm) after surgery.
OtherDaily prevalence of delirium during postoperative days 1-7During the first 7 days after surgeryDaily prevalence of delirium during postoperative days 1-7
OtherDuration of intraoperative cerebral desaturation (sub-study)During surgeryDuration of cerebral desaturation is monitored by near-infrared spectroscopy. Cerebral desaturation is defined as a decrease of more than 10% from baseline. Performed in part of enrolled patients.

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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