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Mortality PredictionNCT03930108

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

An observational study of Mortality Prediction, run by Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

SOFA score is valid for mortality predictor for critically-ill patient in high care and intensive care burn unit Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mortality Prediction
What is being tested?
SOFA score
How many people
169 participants
Where
1 siteIndonesia
Study dates
17 Sep 2018to 17 Feb 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • adult patients (age 18 and above) who admitted to burn unit during sampling period

Who cannot join

  • patients discharged or deceased less than 24 hours of admission
  • patients referred to other hospital within 30 days admission

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Rumah Sakit Cipto Mangunkusumo

    Jakarta Pusat, DKI Jakarta, 10430

Other trials in Indonesia

About this study

Official title: 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

Being tested
SOFA score
Keywords
Burn injury, Mortality prediction, SOFA score, Organ failure
Medical subject headings
Burns

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SOFA scoreOther

    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 in NCT03930108
Study groupRoleWhat they receive
Mortality outcomeNot described
Receives: Other: SOFA score

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SOFA score Discrimination

    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

    Measured: 30 days from admission

  2. SOFA score Calibration

    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

    Measured: 30 days from admission

  3. Correlation between SOFA score variables with outcome

    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

    Measured: 30 days from admission

Secondary outcomes (7)

  1. Patient outcome

    Patient outcome within 30 days of admission to burn units: deceased or survived

    Measured: 30 days from admission

  2. SOFA score: Partial Oxygen Pressure (PaO2)/ Fraction of Inspired Oxygen (FiO2)

    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.

    Measured: Day 1

  3. SOFA score: Mean Arterial Pressure (MAP) or vasoactive agent usage

    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.

    Measured: Day 1

  4. SOFA score: Serum creatinine or 24-hour diuresis

    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.

    Measured: Day 1

  5. SOFA score: Platelet count

    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.

    Measured: Day 1

  6. SOFA score: Serum Bilirubin

    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.

    Measured: Day 1

  7. SOFA score: Glasgow Coma Scale (GCS)

    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.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2019
  2. Study start17 Sep 2018
  3. Primary completion17 Dec 2018
  4. Study completion17 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
169 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03930108
Sponsor's protocol ID
IndonesiaUAnes033
Status last verified
Apr 2019
First submitted
24 Apr 2019
Last updated
29 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

  • Queiroz LF, Anami EH, Zampar EF, Tanita MT, Cardoso LT, Grion CM. Epidemiology and outcome analysis of burn patients admitted to an Intensive Care Unit in a University Hospital. Burns. 2016 May;42(3):655-62. doi: 10.1016/j.burns.2015.08.002. Epub 2016 Jan 4.

    PubMed 26762620

  • 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.

  • Vincent JL, de Mendonca A, Cantraine F, Moreno R, Takala J, Suter PM, Sprung CL, Colardyn F, Blecher S. Use of the SOFA score to assess the incidence of organ dysfunction/failure in intensive care units: results of a multicenter, prospective study. Working group on "sepsis-related problems" of the European Society of Intensive Care Medicine. Crit Care Med. 1998 Nov;26(11):1793-800. doi: 10.1097/00003246-199811000-00016.

    PubMed 9824069

  • Snell JA, Loh NH, Mahambrey T, Shokrollahi K. Clinical review: the critical care management of the burn patient. Crit Care. 2013 Oct 7;17(5):241. doi: 10.1186/cc12706.

    PubMed 24093225

  • Jain A, Palta S, Saroa R, Palta A, Sama S, Gombar S. Sequential organ failure assessment scoring and prediction of patient's outcome in Intensive Care Unit of a tertiary care hospital. J Anaesthesiol Clin Pharmacol. 2016 Jul-Sep;32(3):364-8. doi: 10.4103/0970-9185.168165.

    PubMed 27625487

  • Cardenas-Turanzas M, Ensor J, Wakefield C, Zhang K, Wallace SK, Price KJ, Nates JL. Cross-validation of a Sequential Organ Failure Assessment score-based model to predict mortality in patients with cancer admitted to the intensive care unit. J Crit Care. 2012 Dec;27(6):673-80. doi: 10.1016/j.jcrc.2012.04.018. Epub 2012 Jul 2.

    PubMed 22762932

  • 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.

  • Nair R, Bhandary NM, D'Souza AD. Initial Sequential Organ Failure Assessment score versus Simplified Acute Physiology score to analyze multiple organ dysfunction in infectious diseases in Intensive Care Unit. Indian J Crit Care Med. 2016 Apr;20(4):210-5. doi: 10.4103/0972-5229.180041.

    PubMed 27303136

  • Cabre L, Mancebo J, Solsona JF, Saura P, Gich I, Blanch L, Carrasco G, Martin MC; Bioethics Working Group of the SEMICYUC. Multicenter study of the multiple organ dysfunction syndrome in intensive care units: the usefulness of Sequential Organ Failure Assessment scores in decision making. Intensive Care Med. 2005 Jul;31(7):927-33. doi: 10.1007/s00134-005-2640-2. Epub 2005 Apr 26.

    PubMed 15856171

  • Lorente JA, Vallejo A, Galeiras R, Tomicic V, Zamora J, Cerda E, de la Cal MA, Esteban A. Organ dysfunction as estimated by the sequential organ failure assessment score is related to outcome in critically ill burn patients. Shock. 2009 Feb;31(2):125-31. doi: 10.1097/SHK.0b013e31817fc3ef.

    PubMed 18650779

  • 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Mortality Prediction, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SOFA score Discrimination (time frame: 30 days from admission). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03930108, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2019.

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