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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

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

Condition or disease Intervention/treatment
Mortality Prediction Other: SOFA score

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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 17, 2018
Actual Primary Completion Date : December 17, 2018
Actual Study Completion Date : February 17, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

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.




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;

    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.

  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;

    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.

  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;

    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.

  5. 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.

  6. 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.

  7. 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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930108


Locations
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Indonesia
Rumah Sakit Cipto Mangunkusumo
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
Publications:
Wardhana A, Basuki A, Prameswara ADH, Rizkita DN, Andarie AA, Canintika AF. The epidemiology of burns in Indonesia's national referral burn center from 2013 to 2015. Burn Open. 2017;1(2):67-73.
Taofik S, Senapathi TGA, Wiryana M. Comparison Of Validity Apache II, SOFA And Customized Sequential Organ Failure Assessment (Csofa) For Predicting Non-Surgical Patient. J Anestesiol Indones. 2015;7(2):102-13.
Sunaryo A, Redjeki IS, Bisri T. Perbandingan Validasi APACHE II dan SOFA Score untuk Memperkirakan Mortalitas Pasien yang Dirawat di Ruang Perawatan Intensif. Majalah Kedokteran Terapi Intensif. 2012;2(1):11-20.
Andrias A, Hanafie A, Wijaya DW. Comparison of APACHE II, SOFA, and CSOFA Scoring System Validity as Mortality Predictor in ICU Patients in H. Adam Malik General Hospital. J Anestesi Perioper. 2017;5(1):17-23j.
Bouch DC, Thompson JP. Severity scoring systems in the critically ill. Contin Educ Anaesth Crit Care Pain. 2008;8(5):181-5.
de Brito MR, Barros AG, Valler L, Cardoso FB, Gasparotto AP, Tiziani L, et al. Evaluation of Sequential Organ Failure Assessment (SOFA) Performance in Neurocritical Care Patients Overtime: A Retrospective Cohort Study. J Brain Disord. 2017;1(1):38-43.
Karlie J, Wardhana A. External Validation of Belgian Outcome of Burn Injury Score on Burned Patient In Burn Unit Cipto Mangunkusumo General Hospital. New Ropanasuri J Surg. 2017;2(1):90.
Carson J, Goverman J, Fagan S. Acute renal failure in association with thermal injury. In: Herndon D, editor. Total Burn Care. 5th ed. Elsevier; 2018. p. 318-27.
Enkhbaatar P, Sousse L, Cox R, Herndon D. The pathophysiology of inhalation injury. In: Herndon D, editor. Total Burn Care. 5th ed. Elsevier; 2018. p. 174-83.

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Responsible Party: Dita Aditianingsih, MD, PhD, Anesthesiologist Consultant, Indonesia University
ClinicalTrials.gov Identifier: NCT03930108    
Other Study ID Numbers: IndonesiaUAnes033
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dita Aditianingsih, Indonesia University:
Burn injury
Mortality prediction
SOFA score
Organ failure
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes