This website is for US healthcare professionals

close-icon

Log In to Bolder Science

or

Don't have an account? Sign Up

close-icon

Please enter your email address.

You will receive a link to create a new password via email.

Log In

close-icon

Create an Account

or
  • 8 characters minimum
  • First character may not be a number
  • Last character may not be a number
close-icon

Welcome and thank you for creating an account!

At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

Condition Categories

Condition categories are pulled directly from ClinicalTrials.gov. Choose 1 or more condition categories that you are interested in:

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

Set a default location

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

More Information