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

NCT04980274 | Completed

• 1 other identifier: 51
• Study Type: observational
• Target: 1,410
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Critically Ill Patients

Keywords

SOFA SCORE; Delta SOFA; Critically ill patients; Outcomes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 28 day mortality

  28 days

• Length of time without mechanical ventilation

  28 days

• Length of time without vasopressor

  28 days

Study Arms (3)

Group 1

Patients with SOFA score \< 2 on admission

Other: 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)

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)

Interventions

Intervention focused on identified organ dysfunction(s) OTHER

Intervention focused on identified organ dysfunction(s)

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Sao Domingos: lead

Study Sites (1)

Hospital Sao Domingos

São Luís, Maranhão, 65060645, Brazil

Location

Related Publications (6)

• 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.

  PMID: 25241933 BACKGROUND

• 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.

  PMID: 8844239 RESULT

• 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.

  PMID: 10470572 RESULT

• 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.

  PMID: 19325482 RESULT

• 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.

  PMID: 11594901 RESULT

• 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.

  PMID: 28114553 RESULT

Study Officials

• JOSE AZEVEDO, MD, PhD

  HOSPITAL SAO DOMINGOS SAO LUIS, BRAZIL

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD; PhD

Study Record Dates

• First Submitted: July 18, 2021
• First Posted: July 28, 2021
• Study Start: January 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)