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Trial · NCT05637606

Registered outcomes14

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

ListOutcomeTime frameDescription
PrimaryComposite endpoint of postoperative mortality and at least one major organ dysfunction (see description in the secondary outcomes).up to 30 days after operationComposite postoperative outcome
SecondaryHospital stay (days)up to 30 days after operationHospital stay (days)
SecondaryICU stay (days)up to 30 days after operationIntensive Care Unit stay (days)
SecondaryICU readmissionup to 30 days after operationIntensive Care Unit readmissions
SecondarySequential Organ Failure Assessment (SOFA) scores on postoperativeup to 7 days after operationPostoperative organ failure - SOFA scores ranges from 0 (\<2% of mortality) to 24 (\>90% of mortality)
SecondaryOverall intraoperative fluid balanceday 1 after the operationIntraoperative infusions (crystalloids, colloids, blood products) / Intraoperative loss balance (urine output)
SecondaryMortalityup to 30 days after operationMortality
SecondaryVasopressors useday 1 after the operationDose and timing of vasoactive drug infusion intraoperatively
SecondaryNeed for reoperationday 30 after operationNeed of a new surgical treatment
OtherCARDIOVASCULAR complicationsday 7 after operation* Acute heart failure * Myocardial injury after non-cardiac surgery * Myocardial infarction * Bradycardia * Symptomatic proximal deep venous thrombosis * Peripheral arterial and venous thrombosis
OtherNEUROLOGICAL complicationsday 7 after operation* Stroke * Subarachnoid hemorrhage * Cerebral venous thrombosis * Seizure * Acute delirium
OtherRESPIRATORYday 7 after operation
* Acute respiratory distress * Hypoxemia with or without acute respiratory distress * Need for invasive, non-invasive ventilation or high-flow nasal cannula for acute respiratory distress. * Acute respiratory distress syndrome. * Pulmonary edema * Pulmonary embolism
OtherRENALday 7 after operation• Acute Kidney Injury (AKI) and AKI stages defined according to the AKIN classification/staging system of acute kidney injury
OtherSEPSIS and Septic shockday 7 after operation
Based on the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) criteria, sepsis required a quick Sequential Organ Failure Assessment (qSOFA) Score ≥ 2 points due to infection, septic shock defined as indicated by the Surviving Sepsis Campaign Guidelines

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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