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OpenTrials
Completed

NCT Number: NCT04980274

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Sao Domingos

São Luís, Maranhão, 65060645, Brazil

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention focused on identified organ dysfunction(s)

Other

Intervention focused on identified organ dysfunction(s)

Primary outcomes

  1. Improvement in SOFA score after 48 hours of ICU stay

    Time frame: 48 hours

    Interventions designed to reverse or improve the organ dysfunction that motivated a SOFA score equal to or > 2

Secondary outcomes

  1. 28 day mortality

    Time frame: 28 days

    Interventions designed to reverse or improve the organ dysfunction that motivated a SOFA

  2. Length of time without mechanical ventilation

    Time frame: 28 days

    Interventions designed to reverse or improve the organ dysfunction that motivated a SOFA

  3. Length of time without vasopressor

    Time frame: 28 days

    Interventions designed to reverse or improve the organ dysfunction that motivated a SOFA

Sponsors and collaborators

Lead sponsor

Hospital Sao Domingos

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 28, 2021
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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