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

Completed

• Conditions: Critically Ill Patients
• Interventions: Other: Intervention focused on identified organ dysfunction(s)

• Registration Number: NCT04980274
• Lead Sponsor: Hospital Sao Domingos

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-07
• Study First Submitted: 2021-07-18
• Study First Submitted QC: 2021-07-27
• Last Update Submitted: 2021-07-27
• Study First Posted: 2021-07-28
• Last Update Posted: 2021-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1410

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Improvement in SOFA score after 48 hours of ICU stay	48 hours	Interventions designed to reverse or improve the organ dysfunction that motivated a SOFA score equal to or \> 2

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Sao Domingos; 🇧🇷 São Luis, Maranhao, Brazil