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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04980274
Enrollment
1410
Registered
2021-07-28
Start date
2020-01-01
Completion date
2020-12-31
Last updated
2021-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critically Ill Patients

Keywords

SOFA SCORE, Delta SOFA, Critically ill patients, Outcomes

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).

Interventions

OTHERIntervention focused on identified organ dysfunction(s)

Intervention focused on identified organ dysfunction(s)

Sponsors

Hospital Sao Domingos
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Improvement in SOFA score after 48 hours of ICU stay48 hoursInterventions designed to reverse or improve the organ dysfunction that motivated a SOFA score equal to or \> 2

Secondary

MeasureTime frameDescription
28 day mortality28 daysInterventions designed to reverse or improve the organ dysfunction that motivated a SOFA
Length of time without mechanical ventilation28 daysInterventions designed to reverse or improve the organ dysfunction that motivated a SOFA
Length of time without vasopressor28 daysInterventions designed to reverse or improve the organ dysfunction that motivated a SOFA

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026