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

April 24, 2019 updated by: Dita Aditianingsih, Indonesia University

Validity of Sequential Organ Failure Assessment (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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

169

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Rumah Sakit Cipto Mangunkusumo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Medical record of adult patients in burn units during a period between January 2012 and December 2017

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days from admission
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
30 days from admission
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
30 days from admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient outcome
Time Frame: 30 days from admission
Patient outcome within 30 days of admission to burn units: deceased or survived
30 days from admission
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.
Day 1
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.
Day 1
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.
Day 1
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.
Day 1
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.
Day 1
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.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2018

Primary Completion (Actual)

December 17, 2018

Study Completion (Actual)

February 17, 2019

Study Registration Dates

First Submitted

April 24, 2019

First Submitted That Met QC Criteria

April 24, 2019

First Posted (Actual)

April 29, 2019

Study Record Updates

Last Update Posted (Actual)

April 29, 2019

Last Update Submitted That Met QC Criteria

April 24, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IndonesiaUAnes033

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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