NCT03930108

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 17, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 29, 2019

Completed
Last Updated

April 29, 2019

Status Verified

April 1, 2019

Enrollment Period

3 months

First QC Date

April 24, 2019

Last Update Submit

April 24, 2019

Conditions

Mortality Prediction

Keywords

Burn injuryMortality predictionSOFA scoreOrgan failure

Outcome Measures

Primary Outcomes (3)

  • 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

    30 days from admission

  • 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

    30 days from admission

  • 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

    30 days from admission

Secondary Outcomes (7)

  • Patient outcome

    30 days from admission

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

    Day 1

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

    Day 1

  • SOFA score: Serum creatinine or 24-hour diuresis

    Day 1

  • SOFA score: Platelet count

    Day 1

  • +2 more secondary outcomes

Study Arms (1)

Mortality outcome

Other: SOFA score

Interventions

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.

Mortality outcome

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rumah Sakit Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Publications (22)

  • 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.

    BACKGROUND

  • 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.

    PMID: 26762620BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • Bouch DC, Thompson JP. Severity scoring systems in the critically ill. Contin Educ Anaesth Crit Care Pain. 2008;8(5):181-5.

    BACKGROUND

  • 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.

    PMID: 9824069BACKGROUND

  • 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.

    PMID: 24093225BACKGROUND

  • 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.

    PMID: 27625487BACKGROUND

  • 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.

    PMID: 22762932BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 27303136BACKGROUND

  • 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.

    PMID: 15856171BACKGROUND

  • 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.

    PMID: 18650779BACKGROUND

  • 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.

    BACKGROUND

  • Emara SS, Alzaylai AA. Renal failure in burn patients: a review. Ann Burns Fire Disasters. 2013 Mar 31;26(1):12-5.

    PMID: 23966893BACKGROUND

  • Ibrahim AE, Sarhane KA, Fagan SP, Goverman J. Renal dysfunction in burns: a review. Ann Burns Fire Disasters. 2013 Mar 31;26(1):16-25.

    PMID: 23966894BACKGROUND

  • 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.

    BACKGROUND

  • Nielson CB, Duethman NC, Howard JM, Moncure M, Wood JG. Burns: Pathophysiology of Systemic Complications and Current Management. J Burn Care Res. 2017 Jan/Feb;38(1):e469-e481. doi: 10.1097/BCR.0000000000000355.

    PMID: 27183443BACKGROUND

  • 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.

    BACKGROUND

  • Marck RE, Montagne HL, Tuinebreijer WE, Breederveld RS. Time course of thrombocytes in burn patients and its predictive value for outcome. Burns. 2013 Jun;39(4):714-22. doi: 10.1016/j.burns.2013.01.015. Epub 2013 Mar 13.

    PMID: 23490002BACKGROUND

  • Guo F, Wang X, Huan J, Liang X, Chen B, Tang J, Gao C. Association of platelet counts decline and mortality in severely burnt patients. J Crit Care. 2012 Oct;27(5):529.e1-7. doi: 10.1016/j.jcrc.2011.12.006. Epub 2012 Feb 1.

    PMID: 22300492BACKGROUND

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Anesthesiologist Consultant

Study Record Dates

First Submitted

April 24, 2019

First Posted

April 29, 2019

Study Start

September 17, 2018

Primary Completion

December 17, 2018

Study Completion

February 17, 2019

Last Updated

April 29, 2019

Record last verified: 2019-04

Locations

ID(1)