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

Mortality Prediction Clinical Trial

Official title:

Validity of Sequential Organ Failure Assessment (SOFA) Score as Predictor of Mortality in Critically-ill Burn Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03930108
• Other study ID #: IndonesiaUAnes033
• Status: Completed
• Start date: September 17, 2018
• Est. completion date: February 17, 2019

Study information

• Verified date: April 2019
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: February 17, 2019
• Est. primary completion date: December 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Mortality Prediction

Intervention

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.

Locations

Country	Name	City	State
Indonesia	Rumah Sakit Cipto Mangunkusumo	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (22)

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.

Cabré L, Mancebo J, Solsona JF, Saura P, Gich I, Blanch L, Carrasco G, Martín 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. Epub 2005 Apr 26. — View Citation

Cárdenas-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. — View Citation

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.

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.

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

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.

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. — View Citation

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. — View Citation

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. — View Citation

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.

Lorente JA, Vallejo A, Galeiras R, Tómicic V, Zamora J, Cerdá 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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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.

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.

Vincent JL, de Mendonça 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. — View Citation

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.

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Patient outcome	Patient outcome within 30 days of admission to burn units: deceased or survived	30 days from admission
Secondary	SOFA score: Partial Oxygen Pressure (PaO2)/ Fraction of Inspired Oxygen (FiO2)	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.	Day 1
Secondary	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; 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.	Day 1
Secondary	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; 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.	Day 1
Secondary	SOFA score: Platelet count	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.	Day 1
Secondary	SOFA score: Serum Bilirubin	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.	Day 1
Secondary	SOFA score: Glasgow Coma Scale (GCS)	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.	Day 1