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Trial · NCT04138394

Registered outcomes17

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

ListOutcomeTime frameDescription
PrimaryPersistent Organ Dysfunction + Deathat 28 days
Persistent organ dysfunction (PODS)+death, a novel composite endpoint that combines being alive and being free of organ support (inotropes or vasopressors, renal replacement therapy and mechanical ventilation)
SecondaryTime to discharge alive from hospital90 days
Time to discharge alive from hospital, a composite of mortality and length of stay is similar to "ventilator- free days", which is a widely accepted and commonly used outcome in intensive care research.
SecondaryComponents of PODS+28-day mortality28 daysMortality at 28 days / Use of inotropes or vasopressors at 28 days / Renal replacement therapy at 28 days / On mechanical ventilation at 28 days.
SecondaryPOD (persistent organ dysfunction)-free days28 daysAll days free from persistent organ dysfunction within the first 28 days after admission
OtherICU length of stay90 daysDuration of time in the ICU
OtherDuration of mechanical ventilation90 daysLength of time on mechanical ventilation, including still on mechanical ventilation at time of discharge.
OtherICU readmission rate90 daysIncidents of readmission to ICU from within the hospital
OtherHospital mortality90 daysDid the patient die in hospital or was the patient discharged?
OtherHospital length of stay90 daysDuration of time in the hospital
OtherGram negative bacteremia90 daysVenous or arterial blood cultures that show bacteremia with Gram-negative bacilli
Other6 month mortality6 monthsIs the patient alive or deceased 6 months post admission.
OtherHealth-related quality of life6 monthsAdministration of the SF-36 questionnaire 6 months post admission
OtherHealth related quality of life6 monthsAdministration of the Katz-ADL (activities of daily living) questionnaire 6 months post admission. This assessment is scored from 0 - 6 with a higher score indicating better functioning.
OtherHealth related quality of life6 months
Administration of the Lawton-IADL (Instrumental Activities of Daily Living) questionnaire 6 months post admission. This assessment is scored from 0 - 8 with a higher score indicating better functioning.
OtherBurn related procedures90Frequency of operative procedures for burn care.
OtherBlood products given8 daysType and volume of blood products given.
OtherInhalation injury24 hoursThe presence or absence of smoke inhalation injury and whether confirmed by bronchoscopy.

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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