Impact of Interventions on Admissional SOFA Score on Clinical Outcomes of Critically Ill Patients
Study Details
Study Description
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 score and 28 days mortality. The secondary outcome measures comprised the evaluation of standardized interventions on ICU and hospital length of stay ; duration of mechanical ventilation and time using vasoactive drugs. Uni and multivariate statistical analysis will be used to determine organ failures associated to outcome.
Methods: Interventional prospective cohort study involving patients admitted to three ICUs of a tertiary hospital from April 01, 2023 to March 31, 2024. Whenever an admission SOFA score ≥ 2 is identified a standardized protocol of interventions is implemented in the therapeutic plan of the patient (Table 1). A new SOFA score after 48 hours will determine the tendency of the SOFA Score (Delta SOFA) and the result will be correlated with the 28-day mortality
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Table 1. SOFA standardized protocol
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Respiratory Protective mechanical ventilation; mechanical power < 16, NIV Prevention of PSILI: ROX and HACOR index
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Hemodynamic SOSD protocol; Pressoric target; Lactate clearance
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Neurologic Image; EEG; Sedation goals
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Hematologic Basic disease approach; drugs; DDAVP use
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Renal Avoid nephrotoxicity; Avoide hypotension
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Hepatic Avoid hepatotoxic drugs; basic disease approach.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Group 1 Patients with SOFA score < 2 at admission. No intervention |
|
| Group 2 Patients with SOFA score equal to or > 2 on admission and who improved after 48 hours of treatment. Intervention focused on identified organ dysfunction(s) |
Combination Product: Standardized interventions
Standardized interventions according organ dysfunction
|
| Group 3 Patients with SOFA score equal to or > 2 on admission and who did not improve after 48 hours of treatment. Intervention focused on identified organ dysfunction(s) |
Combination Product: Standardized interventions
Standardized interventions according organ dysfunction
|
Outcome Measures
Primary Outcome Measures
- Impact of standardized interventions in respiratory dysfunction on 48-hour delta SOFA [48 hours]
Lung protective ventilation: Tidal volume = 6 ml/kg; Plateau pressure < 28 mmHg; driving pressue < 16 cm H2O; Mechanical power < 16 Joules/min; Prevention of self-inflicted lung injury (P-SILI): ROX index > 4.8 and HACOR < 5.
- Impact of standardized interventions in hemodinamic dysfunction on 48-hour delta SOFA [48 hour]
SOSD (salvage, optimization, stabilization and de-escalation ) protocol; mean arterial pressoric taget of at least 65 mm Hg, Lactate serum level < 19 mg/dL.
- Impact of standardized interventions in neurologic dysfunction on 48-hour delta SOFA [48 hour]
Image: cranial CT; Electroencephalografic monitoring and RASS Score between -1 and +1
- Impact of standardized interventions in hematologic dysfunction on 48-hour delta SOFA [48 hour]
Basic disease approach; avoid drugs that interfere with coagulation; Platelet transfusion in case of hemohhage; DDAVP when indicated.
- Impact of standardized interventions iin renal dysfunction on 48-hour delta SOFA [48 hour]
Avoid nephotoxic drugs; Mantain mean arterial blood pressure > 65 mmHg
- Impact of standardized interventions in hepatic dysfunction on 48-hour delta SOFA [48 hour]
Avoid hepatotoxic drugs;basic disease approach
Secondary Outcome Measures
- Impact of standardized interventions in respiratory dysfunction on 48-hour delta SOFA [28 days]
Lung protective ventilation: Tidal volume 6 ml/kg; Pateau pressure < 28 mmHg; driving pressue < 16 cm H2O; Mechanical power < 16 Joules/min; Prevention of self-inflicted lung injury (P-SILI): ROX index > 4.8 and HACOR < 5.
- Impact of standardized interventions in hemodinamic dysfuction on 48-hour delta SOFA [28 days]
SOSD (salvage, optimization, stabilixation and de-escalation ) protocol; mean arterial pressoric taget of at least 65 mm Hg, Lactate serum level < 19 mg/dL.
- Impact of standardized interventions in neurologic dysfunction on 48-hour delta SOFA [28 days]
Image: cranial CT; Electroencephalografic monitoring and RASS Score between -1 and +1
- Impact of standardized interventions in hematologic dysfunction on 48-hour delta SOFA [28 days]
Basic disease approach; avoid drugs that interfere with coagulation; Platelet transfusion in case of hemohhage; DDAVP when indicated.
- Impact of standardized interventions iin renal dysfunction on 48-hour delta SOFA [28 days]
Avoid nephotoxic drugs; Mantain mean arterial blood pressure > 65 mmHg
- Impact of standardized interventions in hepatic dysfunction on 48-hour delta SOFA [28 days]
Avaoid hepatotoxic drugs;basic disease approach
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients aged above 18 years,
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Lenght of ICU stay of at least 3 days.
Exclusion Criteria:
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Pregnant patients
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End-of-life
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Patients readmitted to the ICU in the same hospitalization
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Hospital Sao Domingos
Investigators
- Study Director: JOSE R AZEVEDO, MD, PhD, Hospital Sao Domingos
- Principal Investigator: BARBARA L RIBEIRO, MD, Hospital Sao Domingos
Study Documents (Full-Text)
None provided.More Information
Publications
- HSD 2023 1