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

Study Overview
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Brief Summary
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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).

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

Conditions
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Critically Ill Patients

Intervention / Treatment
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* Other: Intervention focused on identified organ dysfunction(s)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Patients with SOFA score < 2 on admission | Other: Intervention focused on identified organ dysfunction(s)<br>* Intervention focused on identified organ dysfunction(s)<br>|
| Group 2<br>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)<br>* Intervention focused on identified organ dysfunction(s)<br>|
| Group 3<br>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)<br>* Intervention focused on identified organ dysfunction(s)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28 day mortality | Interventions designed to reverse or improve the organ dysfunction that motivated a SOFA | 28 days | 
| Length of time without mechanical ventilation | Interventions designed to reverse or improve the organ dysfunction that motivated a SOFA | 28 days | 
| Length of time without vasopressor | Interventions designed to reverse or improve the organ dysfunction that motivated a SOFA | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SOFA SCORE, Delta SOFA, Critically ill patients, Outcomes