Clinical trial NCT05790915: Impact of Interventions on Admission SOFA Score on Clinical Outcomes of Critically Ill Patients
Official title: Impact of Interventions on Admission SOFA Score on Clinical Outcomes of Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critically Ill Patients
Keywords: SOFA Score
Delta SOFA
Critically ill patients
Interventions
Outcomes
Lead sponsor: Hospital Sao Domingos
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 849
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients admitted to a medical ICU, a Surgical ICU and a High complexity surgical and trauma ICU in the period from April 01, 2023 to March 31, 2024 and lenght of stay of at least 3 days.

Brief summary: Introduction: The SOFA score (Sequential Organ Function Assessment) and its derived measures, such as the Delta SOFA, are used worldwide to determine the severity and prognosis of critically ill patients.

Objectives: The primary objective of this study was to assess the impact of standardized interventions on the six organ dysfunctions of SOFA score on outcomes of critically ill patients through the 48-hour delta SOFA with evaluation of the effectiveness of the interventions performed. Result will be correlated with the 28-day mortality.

The secondary outcome measures comprised the evaluation of standardized interventions on ICU and hospital length of stay; vasopressor-free and ventilator-free days within the 28 days following ICU admission, through the effectiveness of interventions performed Uni and multivariate statistical analysis will be used to determine organ failures associated to outcome.

Detailed description: This prospective, observational cohort study will include patients admitted to a medical ICU (12 beds), a surgical ICU (13 beds), and a high complexity surgical and trauma ICU (12 beds). of a tertiary hospital from August 01, 2023 to January31, 2024. The trial will include all patients aged above 18 years, admitted to the ICU for at least 3 days. Patients will be excluded for the following reasons: if they are pregnant, moribund and patients readmitted to the ICU in the same hospital admission.

For the patients who met the inclusion criteria, we will collect the demographic data regarding the age, gender, the admission category (medical or surgical), the primary admission diagnosis, the simplified acute physiology score III (SAPS 3), admission sequential organ failure assessment (SOFA) and 48-hour SOFA.

Whenever the admission SOFA score is ≥ 2, the result will be presented to the attending physician who will establish in the therapeutic plan the interventions for each of the dysfunctions identified according to a standardized intervention protocol (Table 1). After 48 hours, a new SOFA score is determined, while the prospective clinical surveillance team simultaneously identify if the interventions proposed by the protocol for each of the organ dysfunctions were effectively implemented.

Three groups of patients will be identified based on their SOFA scores at admission and the 48-hour delta SOFA values: those with an admission SOFA score \< 2 (Group1), those with an admission SOFA score ≥ 2 whose delta SOFA reflected improvement at the end of 48 hours after admission (SOFA after 48 hours \< SOFA on admission) (Group 2, n= ) and finally, those with an admission SOFA score ≥ 2 whose SOFA score increased or remained unchanged at the end of 48 hours postadmission (SOFA after 48 hours ≥ admission SOFA) (Group 3, n= ). The effectiveness of the interventions on organic disfunction will be evaluated in the groups 2 and 3 through the formula:

Number of patients with an organic disfunction and effective intervention / Number of patients with that organic dysfunction X 100

Results will be correlated with 28-day mortality.

Table 1. SOFA standardized protocol

1. Respiratory Protective mechanical ventilation; mechanical power \< 16 NIV Prevention of P-SILI: ROX and HACOR index
2. Hemodynamic SOSD protocol; Pressoric target; Lactate clearance
3. Neurologic Image; EEG; Sedation goals
4. Hematologic Basic disease approach; drugs; DDAVP use; platelet transfusion
5. Renal Avoid nephrotoxicity; Avoid hypotension
6. Hepatic Avoid hepatotoxic drugs; basic disease approach.

NIV, Non-invasive ventilation; P-SILI, patient self-inflicted lung injury; ROX, ratio of oxygen saturation index; HACOR, Heart rate, acidosis, consciousness oxygenatrion and respiratory rate; SOSD, salvage, optimization, stabilization and de-escalation; DDAVP, 1-desamino-8-d-arginine-vasopresssin.

Eligibility criteria: Inclusion Criteria:

* Patients aged above 18 years,
* Lenght of ICU stay of at least 3 days.

Exclusion Criteria:

* Pregnant patients
* End-of-life
* Patients readmitted to the ICU in the same hospitalization

Primary outcomes:
measure: Impact of standardized interventions in respiratory dysfunction on 48-hour delta SOFA with evaluation of the effectiveness of the interventions performed.
timeFrame: 48 hours
measure: Impact of standardized interventions in hemodinamic dysfunction on 48-hour delta SOFA
timeFrame: 48 hour
measure: Impact of standardized interventions in neurologic dysfunction on 48-hour delta SOFA
timeFrame: 48 hour
measure: Impact of standardized interventions in hematologic dysfunction on 48-hour delta SOFA
timeFrame: 48 hour
measure: Impact of standardized interventions iin renal dysfunction on 48-hour delta SOFA
timeFrame: 48 hour
measure: Impact of standardized interventions in hepatic dysfunction on 48-hour delta SOFA
timeFrame: 48 hour
Secondary outcomes:
measure: Impact of standardized interventions in respiratory dysfunction on ICU length of stay
timeFrame: 28 days
measure: Impact of standardized interventions in hemodinamic dysfuction on ICU length of stay
timeFrame: 28 days
measure: Impact of standardized interventions in neurologic dysfunction on ICU length of stay
timeFrame: 28 days
measure: Impact of standardized interventions in hematologic dysfunction on ICU length of stay
timeFrame: 28 days
measure: Impact of standardized interventions iin renal dysfunction on ICU length of stay
timeFrame: 28 days
measure: Impact of standardized interventions in hepatic dysfunction on ICU length of stay
timeFrame: 28 days
measure: Impact of standardized interventions in respiratory dysfunction on vasopressor-free days
timeFrame: 28 days
measure: Impact of standardized interventions in hemodinamic dysfuction on vasopressor-free days
timeFrame: 28 days
measure: Impact of standardized interventions in neurologic dysfunction on vasopressor-free days
timeFrame: 28 days
measure: Impact of standardized interventions in hematologic dysfunction on vasopressor-free days
timeFrame: 28 days
measure: Impact of standardized interventions iin renal dysfunction on vasopressor-free days
timeFrame: 28 days
measure: Impact of standardized interventions in hepatic dysfunction on vasopressor-free days
timeFrame: 28 days
measure: Impact of standardized interventions in respiratory dysfunction on ventilator-free days
timeFrame: 28 days
measure: Impact of standardized interventions in hemodinamic dysfuction on ventilator-free days
timeFrame: 28 days
measure: Impact of standardized interventions in neurologic dysfunction on ventilator-free days
timeFrame: 28 days
measure: Impact of standardized interventions in hematologic dysfunction on ventilator-free days
timeFrame: 28 days
measure: Impact of standardized interventions iin renal dysfunction on ventilator-free days
timeFrame: 28 days
measure: Impact of standardized interventions in hepatic dysfunction on ventilator-free days
timeFrame: 28 days
measure: Impact of standardized interventions in respiratory dysfunction on hospital length of stay
timeFrame: 60 days
measure: Impact of standardized interventions in hemodinamic dysfuction on hospital length of stay
timeFrame: 60 days
measure: Impact of standardized interventions in neurologic dysfunction on hospital length of stay
timeFrame: 60 days
measure: Impact of standardized interventions in hematologic dysfunction on hospital length of stay
timeFrame: 60 days
measure: Impact of standardized interventions in renal dysfunction on hospital length of stay
timeFrame: 60 days
measure: Impact of standardized interventions in hepatic dysfunction on hospital length of stay
timeFrame: 60 days
Other outcomes:
Locations:
city: Sao Luis
country: Brazil
facility: Hospital Sao Domingos
state: MA
Study officials:
affiliation: Hospital Sao Domingos
name: JOSE R AZEVEDO, MD, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Sao Domingos
name: BARBARA L RIBEIRO, MD
role: PRINCIPAL_INVESTIGATOR
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