Clinical trial NCT04980274: Impact of Admission SOFA Score and 48-hour Delta SOFA on Clinical Outcomes in Critically Ill Patients
Official title: Impact of Admission SOFA Score and 48-hour Delta SOFA on Clinical Outcomes in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critically Ill Patients
Keywords: SOFA SCORE
Delta SOFA
Critically ill patients
Outcomes
Lead sponsor: Hospital Sao Domingos
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 1410
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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).


Eligibility criteria: 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

Primary outcomes:
measure: Improvement in SOFA score after 48 hours of ICU stay
timeFrame: 48 hours
Secondary outcomes:
measure: 28 day mortality
timeFrame: 28 days
measure: Length of time without mechanical ventilation
timeFrame: 28 days
measure: Length of time without vasopressor
timeFrame: 28 days
Other outcomes:
Locations:
city: São Luis
country: Brazil
facility: Hospital Sao Domingos
state: Maranhao
Study officials:
affiliation: HOSPITAL SAO DOMINGOS SAO LUIS, BRAZIL
name: JOSE AZEVEDO, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
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: 10.1097/CCM.0b013e31819def97.
citation: 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.
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 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.