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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/18/2021.

Validity of SOFA Score as Predictor of Mortality in Critically-ill Burn Patients

Clinicaltrials.gov identifier NCT03930108

Recruitment Status Completed

First Posted April 29, 2019

Last update posted April 29, 2019

Study Description

Brief summary:

SOFA score is valid for mortality predictor for critically-ill patient in high care and intensive care burn unit

  • Condition or Disease:Mortality Prediction
  • Intervention/Treatment: Other: SOFA score
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Actual Enrollment: 169 participants
  • Observational Model: Cohort
  • Time Perspective: Retrospective
  • Official Title: Validity of Sequential Organ Failure Assessment (SOFA) Score as Predictor of Mortality in Critically-ill Burn Patients
  • Actual Study Start Date: September 2018
  • Actual Primary Completion Date: December 2018
  • Actual Study Completion Date: February 2019
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: Mortality outcome
Other: SOFA score
Variables of sequential organ failure assessment score, including: P:F ratio; MAP or vasoactive treatment; creatinine or 24-h diuresis; platelet count; serum bilirubin; GCS.
Outcome Measures
  • Primary Outcome Measures: 1. SOFA score Discrimination [ Time Frame: 30 days from admission ]
    SOFA score ability to discriminate outcomes based on variable scores: PaO2/FiO2; MAP/vasoactive treatment; serum creatinine or 24-h diuresis; platelet count; serum bilirubin; GCS
  • 2. SOFA score Calibration [ Time Frame: 30 days from admission ]
    SOFA score cutoff to predict outcome based on variable scores: PaO2/FiO2; MAP/vasoactive treatment; serum creatinine or 24-h diuresis; platelet count; serum bilirubin; GCS
  • 3. Correlation between SOFA score variables with outcome [ Time Frame: 30 days from admission ]
    Correlation between patient outcomes with each SOFA score variable: PaO2/FiO2; MAP/vasoactive treatment; serum creatinine or 24-h diuresis; platelet count; serum bilirubin; GCS
  • Secondary Outcome Measures: 1. Patient outcome [ Time Frame: 30 days from admission ]
    Patient outcome within 30 days of admission to burn units: deceased or survived
  • 2. SOFA score: Partial Oxygen Pressure (PaO2)/ Fraction of Inspired Oxygen (FiO2) [ Time Frame: Day 1 ]
    The score for PaO2/FiO2 variable cutoff: 0 point for >400 mmHg; point for <400 mmHg; points for <300 mmHg; points for <200 mmHg with respiratory support; points for <100 mmHg with respiratory support.
  • 3. SOFA score: Mean Arterial Pressure (MAP) or vasoactive agent usage [ Time Frame: Day 1 ]
    The score for MAP or vasoactive agent usage variable cutoff: 0 point for MAP >=70 mmHg; point for MAP <70 mmHg; points for dopamine <= 5 mcg/kg/min OR dobutamine any dose; points for dopamine >5 mcg/kg/min OR norepinephrine or epinephrine <=0.1 mcg/kg/min; points for dopamine >15 mcg/kg/min OR norepinephrine or epinephrine >0.1 mcg/kg/min.
  • 4. SOFA score: Serum creatinine or 24-hour diuresis [ Time Frame: Day 1 ]
    The score for serum creatinine or 24-hour diuresis variable cutoff: 0 point for creatinine <1.2 mg/dL; point for creatinine 1.2 - 1.9 mg/dL; points for creatinine 2.0 - 3.4 mg/dL; points for creatinine 3.5 - 4.9 mg/dL OR diuresis <500 mL/24h; points for creatinine >5.0 mg/dL OR diuresis <200 mL/24h.
  • 5. SOFA score: Platelet count [ Time Frame: Day 1 ]
    The score for platelet count variable cutoff: 0 point for >=150 x10^3/mm^3; point for <150 x10^3/mm^3; points for <100 x10^3/mm^3; points for <50 x10^3/mm^3; points for <20 x10^3/mm^3.
  • 6. SOFA score: Serum Bilirubin [ Time Frame: Day 1 ]
    The score for serum bilirubin variable cutoff: 0 point for <1.2 mg/dL; point for 1.2 - 1.9 mg/dL; points for 2.0 - 5.9 mg/dL; points for 6.0 - 11.9 mg/dL; points for >12.0 mg/dL.
  • 7. SOFA score: Glasgow Coma Scale (GCS) [ Time Frame: Day 1 ]
    The score for GCS variable cutoff: 0 point for 15; point for 13 - 14; points for 10 - 12; points for 6 - 9; points for <6L.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: Medical record of adult patients in burn units during a period between January 2012 and December 2017
Criteria

Inclusion Criteria:

- adult patients (age 18 and above) who admitted to burn unit during sampling period

Exclusion Criteria:

- patients discharged or deceased less than 24 hours of admission

- patients referred to other hospital within 30 days admission

Contacts and Locations
Contacts
Locations

Indonesia, DKI Jakarta
Rumah Sakit Cipto Mangunkusumo
Jakarta Pusat

Sponsors and Collaborators

Indonesia University

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