Validity of SOFA Score as Predictor of Mortality in Critically-ill Burn Patients
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT03930108 Completed April 29, 2019 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
Estimated Enrollment : 169 participants
Intervention Model : N/A
Masking: N/A
Primary Purpose: N/A
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
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
Investigator
More Information
Other Publications

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Responsible Party : Indonesia University
ClinicalTrials.gov Identifier : NCT03930108     
Other Study ID Numbers : IndonesiaUAnes033
First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Last Verified : April 2019
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Indonesia University: Burn injury
Mortality prediction
SOFA score
Organ failure
Additional relevant MeSH terms :
Critical Illness