Impact of Admission SOFA Score and 48-hour Delta SOFA on Clinical Outcomes in Critically Ill Patients

Organ dysfunctions are associated with high morbidity and mortality. The SOFA (Sequential Organ Failure Assessment) score developed by Vincent et al. sequentially assesses the presence and severity of dysfunctions in six organ systems: respiratory, cardiovascular, coagulation, hepatic, neurological and renal. Although the SOFA score was created to quantify organ dysfunctions, the obvious relationship between organ dysfunctions and mortality has been widely documented. Dynamic measurements of the SOFA score assess response to treatment and can be used to search for perpetuating sources of severity and reassess the treatment plan.

The primary objective of this study will be to assess the impact of an admission SOFA score equal to or greater than 2 and subsequent interventions on outcomes related to the 48-hour delta SOFA on ICU and hospital mortality, length of stay in the ICU, duration of mechanical ventilation, time of vasoactive drug use.

Patients will be divided into three groups: those who did not trigger the SOFA trigger on admission to the ICU (Group 1), those who triggered the SOFA trigger and improved on the third day (Group 2) and, finally, those who triggered the SOFA trigger and worsened on the third day (Group 3).

Study Overview

• Status: Completed
• Conditions: Critically Ill Patients
• Intervention / Treatment: Other: Intervention focused on identified organ dysfunction(s)

• Study Type: Observational
• Enrollment (Actual): 1410

Contacts and Locations

Study Locations

• Brazil
  • Maranhao
    • São Luis, Maranhao, Brazil, 65060645
      • Hospital São Domingos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The SOFA score of all patients admitted to the ICU and with inclusion criteria was calculated and whenever the score was equal to or > 2, the attending physician was notified, the dysfunction(s) that resulted in the score was informed and the physician was asked to inform through the therapeutic plan the interventions it would adopt to improve the result after 48 hours

Description

Inclusion Criteria:

• Included all patients over 18 years old admitted to the ICU during the study period

Exclusion Criteria:

• Excluded were patients who remained in the ICU for a period of less than 48 hours and pregnant women

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Patients with SOFA score < 2 on admission	Other: Intervention focused on identified organ dysfunction(s); Intervention focused on identified organ dysfunction(s)
Group 2; Patients with SOFA score equal to or > 2 on admission and who improved after 48 hours of treatment	Other: Intervention focused on identified organ dysfunction(s); Intervention focused on identified organ dysfunction(s)
Group 3; Patients with SOFA score equal to or > 2 on admission and who did not improve after 48 hours of treatment	Other: Intervention focused on identified organ dysfunction(s); Intervention focused on identified organ dysfunction(s)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in SOFA score after 48 hours of ICU stay	Interventions designed to reverse or improve the organ dysfunction that motivated a SOFA score equal to or > 2	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28 day mortality	Interventions designed to reverse or improve the organ dysfunction that motivated a SOFA	28 days
Length of time without mechanical ventilation	Interventions designed to reverse or improve the organ dysfunction that motivated a SOFA	28 days
Length of time without vasopressor	Interventions designed to reverse or improve the organ dysfunction that motivated a SOFA	28 days

Collaborators and Investigators

• Sponsor: Hospital Sao Domingos
• Investigators: Study Director: JOSE AZEVEDO, MD, PhD, HOSPITAL SAO DOMINGOS SAO LUIS, BRAZIL

Publications and helpful links

General Publications

• Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10. doi: 10.1007/BF01709751. No abstract available.
• Ferreira FL, Bota DP, Bross A, Melot C, Vincent JL. Serial evaluation of the SOFA score to predict outcome in critically ill patients. JAMA. 2001 Oct 10;286(14):1754-8. doi: 10.1001/jama.286.14.1754.
• Moreno R, Vincent JL, Matos R, Mendonca A, Cantraine F, Thijs L, Takala J, Sprung C, Antonelli M, Bruining H, Willatts S. The use of maximum SOFA score to quantify organ dysfunction/failure in intensive care. Results of a prospective, multicentre study. Working Group on Sepsis related Problems of the ESICM. Intensive Care Med. 1999 Jul;25(7):686-96. doi: 10.1007/s001340050931.
• Raith EP, Udy AA, Bailey M, McGloughlin S, MacIsaac C, Bellomo R, Pilcher DV; Australian and New Zealand Intensive Care Society (ANZICS) Centre for Outcomes and Resource Evaluation (CORE). Prognostic Accuracy of the SOFA Score, SIRS Criteria, and qSOFA Score for In-Hospital Mortality Among Adults With Suspected Infection Admitted to the Intensive Care Unit. JAMA. 2017 Jan 17;317(3):290-300. doi: 10.1001/jama.2016.20328.
• de Azevedo JR, Torres OJ, Beraldi RA, Ribas CA, Malafaia O. Prognostic evaluation of severe sepsis and septic shock: procalcitonin clearance vs Delta Sequential Organ Failure Assessment. J Crit Care. 2015 Feb;30(1):219.e9-12. doi: 10.1016/j.jcrc.2014.08.018. Epub 2014 Sep 10.
• Jones AE, Trzeciak S, Kline JA. The Sequential Organ Failure Assessment score for predicting outcome in patients with severe sepsis and evidence of hypoperfusion at the time of emergency department presentation. Crit Care Med. 2009 May;37(5):1649-54. doi: 10.1097/CCM.0b013e31819def97.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: July 18, 2021
• First Submitted That Met QC Criteria: July 27, 2021
• First Posted (Actual): July 28, 2021

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 27, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Outcomes; Critically ill patients; SOFA SCORE; Delta SOFA
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 51

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No