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

Critically Ill Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04980274
• Other study ID #: 51
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2021
• Source: Hospital Sao Domingos
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1410
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill Patients

Intervention

Other:
• Intervention focused on identified organ dysfunction(s)
Intervention focused on identified organ dysfunction(s)

Locations

Country	Name	City	State
Brazil	Hospital Sao Domingos	São Luis	Maranhao

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Sao Domingos

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

de Azevedo JR, Torres OJ, Beraldi RA, Ribas CA, Malafaia O. Prognostic evaluation of severe sepsis and septic shock: procalcitonin clearance vs ? 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. — View Citation

Ferreira FL, Bota DP, Bross A, Mélot C, Vincent JL. Serial evaluation of the SOFA score to predict outcome in critically ill patients. JAMA. 2001 Oct 10;286(14):1754-8. — View Citation

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: — View Citation

Moreno R, Vincent JL, Matos R, Mendonça 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. W — View Citation

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 Sc — View Citation

Vincent JL, Moreno R, Takala J, Willatts S, De Mendonça 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 Proble — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	28 day mortality	Interventions designed to reverse or improve the organ dysfunction that motivated a SOFA	28 days
Secondary	Length of time without mechanical ventilation	Interventions designed to reverse or improve the organ dysfunction that motivated a SOFA	28 days
Secondary	Length of time without vasopressor	Interventions designed to reverse or improve the organ dysfunction that motivated a SOFA	28 days