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NCT Number: NCT03930108

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

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

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Key information

Conditions

Mortality Prediction Burns Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rumah Sakit Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SOFA score

Other

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

Validity of Sequential Organ Failure Assessment (SOFA) Score as Predictor of Mortality in Critically-ill Burn Patients

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Apr 29, 2019
Registry last updated
Apr 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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