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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03930108
Recruitment Status : Completed
First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Dita Aditianingsih, Indonesia University

Tracking Information
First Submitted Date April 24, 2019
First Posted Date April 29, 2019
Last Update Posted Date April 29, 2019
Actual Study Start Date September 17, 2018
Actual Primary Completion Date December 17, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 24, 2019)
  • 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
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 24, 2019)
  • Patient outcome [ Time Frame: 30 days from admission ]
    Patient outcome within 30 days of admission to burn units: deceased or survived
  • 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;
    1. point for <400 mmHg;
    2. points for <300 mmHg;
    3. points for <200 mmHg with respiratory support;
    4. points for <100 mmHg with respiratory support.
  • 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;
    1. point for MAP <70 mmHg;
    2. points for dopamine <= 5 mcg/kg/min OR dobutamine any dose;
    3. points for dopamine >5 mcg/kg/min OR norepinephrine or epinephrine <=0.1 mcg/kg/min;
    4. points for dopamine >15 mcg/kg/min OR norepinephrine or epinephrine >0.1 mcg/kg/min.
  • 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;
    1. point for creatinine 1.2 - 1.9 mg/dL;
    2. points for creatinine 2.0 - 3.4 mg/dL;
    3. points for creatinine 3.5 - 4.9 mg/dL OR diuresis <500 mL/24h;
    4. points for creatinine >5.0 mg/dL OR diuresis <200 mL/24h.
  • SOFA score: Platelet count [ Time Frame: Day 1 ]
    The score for platelet count variable cutoff: 0 point for >=150 x10^3/mm^3;
    1. point for <150 x10^3/mm^3;
    2. points for <100 x10^3/mm^3;
    3. points for <50 x10^3/mm^3;
    4. points for <20 x10^3/mm^3.
  • SOFA score: Serum Bilirubin [ Time Frame: Day 1 ]
    The score for serum bilirubin variable cutoff: 0 point for <1.2 mg/dL;
    1. point for 1.2 - 1.9 mg/dL;
    2. points for 2.0 - 5.9 mg/dL;
    3. points for 6.0 - 11.9 mg/dL;
    4. points for >12.0 mg/dL.
  • SOFA score: Glasgow Coma Scale (GCS) [ Time Frame: Day 1 ]
    The score for GCS variable cutoff: 0 point for 15;
    1. point for 13 - 14;
    2. points for 10 - 12;
    3. points for 6 - 9;
    4. points for <6L.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Validity of SOFA Score as Predictor of Mortality in Critically-ill Burn Patients
Official Title Validity of Sequential Organ Failure Assessment (SOFA) Score as Predictor of Mortality in Critically-ill Burn Patients
Brief Summary SOFA score is valid for mortality predictor for critically-ill patient in high care and intensive care burn unit
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Medical record of adult patients in burn units during a period between January 2012 and December 2017
Condition Mortality Prediction
Intervention 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.
Study Groups/Cohorts Mortality outcome
Intervention: Other: SOFA score
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 24, 2019)
169
Original Actual Enrollment Same as current
Actual Study Completion Date February 17, 2019
Actual Primary Completion Date December 17, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number NCT03930108
Other Study ID Numbers IndonesiaUAnes033
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Dita Aditianingsih, Indonesia University
Study Sponsor Indonesia University
Collaborators Not Provided
Investigators Not Provided
PRS Account Indonesia University
Verification Date April 2019