Impact of Interventions on Admission SOFA Score on Clinical Outcomes of Critically Ill Patients

Completed

• Conditions: Critically Ill Patients
• Interventions: Combination Product: Standardized interventions

• Registration Number: NCT05790915
• Lead Sponsor: Hospital Sao Domingos

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.

Study Timeline

• Study First Submitted: 2023-02-21
• Study First Submitted QC: 2023-03-16
• Study First Posted: 2023-03-30
• Study Start: 2023-08-01
• Primary Completion: 2024-01-30
• Study Completion: 2024-03-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-05-18
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 849

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	Standardized interventions	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)
Group 3	Standardized interventions	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)

Primary Outcome Measures

Name	Time	Method
Impact of standardized interventions in respiratory dysfunction on 48-hour delta SOFA with evaluation of the effectiveness of the interventions performed.	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. The effectiveness of the interventions on organic disfunction will be evaluated through the formula: Number of patients with respiratory dysfunction and effective intervention / Number of patients with respiratory dysfunction X 100
Impact of standardized interventions in hepatic dysfunction on 48-hour delta SOFA	48 hour	Avoid hepatotoxic drugs;basic disease approach The effectiveness of the interventions on organic disfunction will be evaluated through the formula: Number of patients with hepatic dysfunction and effective intervention / Number of patients with hepatic dysfunction X 100
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. The effectiveness of the interventions on organic disfunction will be evaluated through the formula: Number of patients with hemodinamic dysfunction and effective intervention / Number of patients with hemodinamica dysfunction X 100
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 The effectiveness of the interventions on organic disfunction will be evaluated through the formula: Number of patients with neurologic dysfunction and effective intervention / Number of patients with neurologic dysfunction X 100
Impact of standardized interventions iin renal dysfunction on 48-hour delta SOFA	48 hour	Avoid nephotoxic drugs; Mantain mean arterial blood pressure \> 65 mmHg The effectiveness of the interventions on organic disfunction will be evaluated through the formula: Number of patients with renal dysfunction and effective intervention / Number of patients with renal dysfunction X 100
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. The effectiveness of the interventions on organic disfunction will be evaluated through the formula: Number of patients with hematologic dysfunction and effective intervention / Number of patients with hematologic dysfunction X 100

Secondary Outcome Measures

Name	Time	Method
Impact of standardized interventions in hemodinamic dysfuction on ICU length of stay	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. The effectiveness of the interventions on organic disfunction will be evaluated through the formula: Number of patients with hemodinamic dysfunction and effective intervention / Number of patients with hemodinamic dysfunction X 100
Impact of standardized interventions in neurologic dysfunction on ICU length of stay	28 days	Image: cranial CT; Electroencephalografic monitoring and RASS Score between -1 and +1 The effectiveness of the interventions on organic disfunction will be evaluated through the formula: Number of patients with neurologic dysfunction and effective intervention / Number of patients with neurologic dysfunction X 100
Impact of standardized interventions in hematologic dysfunction on ICU length of stay	28 days	Basic disease approach; avoid drugs that interfere with coagulation; Platelet transfusion in case of hemohhage; DDAVP when indicated. The effectiveness of the interventions on organic disfunction will be evaluated through the formula: Number of patients with hematologic dysfunction and effective intervention / Number of patients with hematologic dysfunction X 100
Impact of standardized interventions in respiratory dysfunction on vasopressor-free days	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. The effectiveness of the interventions on organic disfunction will be evaluated through the formula: Number of patients with respiratory dysfunction and effective intervention / Number of patients with respiratory dysfunction X 100
Impact of standardized interventions in neurologic dysfunction on vasopressor-free days	28 days	Image: cranial CT; Electroencephalografic monitoring and RASS Score between -1 and +1 The effectiveness of the interventions on organic disfunction will be evaluated through the formula: Number of patients with neurologic dysfunction and effective intervention / Number of patients with neurologic dysfunction X 100
Impact of standardized interventions in hematologic dysfunction on vasopressor-free days	28 days	Basic disease approach; avoid drugs that interfere with coagulation; Platelet transfusion in case of hemohhage; DDAVP when indicated. The effectiveness of the interventions on organic disfunction will be evaluated through the formula: Number of patients with hematologic dysfunction and effective intervention / Number of patients with hematologic dysfunction X 100
Impact of standardized interventions in respiratory dysfunction on ICU length of stay	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. The effectiveness of the interventions on organic disfunction will be evaluated through the formula: Number of patients with respiratory dysfunction and effective intervention / Number of patients with respiratory dysfunction X 100
Impact of standardized interventions iin renal dysfunction on ICU length of stay	28 days	Avoid nephotoxic drugs; Mantain mean arterial blood pressure \> 65 mmHg The effectiveness of the interventions on organic disfunction will be evaluated through the formula: Number of patients with renal dysfunction and effective intervention / Number of patients with renal dysfunction X 100
Impact of standardized interventions in hemodinamic dysfuction on vasopressor-free days	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. The effectiveness of the interventions on organic disfunction will be evaluated through the formula: Number of patients with hemodinamic dysfunction and effective intervention / Number of patients with hemodinamic dysfunction X 100
Impact of standardized interventions in hepatic dysfunction on ICU length of stay	28 days	Avoid hepatotoxic drugs;basic disease approach The effectiveness of the interventions on organic disfunction will be evaluated through the formula: Number of patients with hepatic dysfunction and effective intervention / Number of patients with hepatic dysfunction X 100
Impact of standardized interventions iin renal dysfunction on vasopressor-free days	28 days	Avoid nephotoxic drugs; Mantain mean arterial blood pressure \> 65 mmHg The effectiveness of the interventions on organic disfunction will be evaluated through the formula: Number of patients with renal dysfunction and effective intervention / Number of patients with renal dysfunction X 100
Impact of standardized interventions iin renal dysfunction on ventilator-free days	28 days	Avoid nephotoxic drugs; Mantain mean arterial blood pressure \> 65 mmHg The effectiveness of the interventions on organic disfunction will be evaluated through the formula: Number of patients with renal dysfunction and effective intervention / Number of patients with renal dysfunction X 100
Impact of standardized interventions in hemodinamic dysfuction on hospital length of stay	60 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. The effectiveness of the interventions on organic disfunction will be evaluated through the formula: Number of patients with hemodinamic dysfunction and effective intervention / Number of patients with hemodinamic dysfunction X 100
Impact of standardized interventions in hematologic dysfunction on hospital length of stay	60 days	Basic disease approach; avoid drugs that interfere with coagulation; Platelet transfusion in case of hemohhage; DDAVP when indicated. The effectiveness of the interventions on organic disfunction will be evaluated through the formula: Number of patients with hematologic dysfunction and effective intervention / Number of patients with hematologic dysfunction X 100
Impact of standardized interventions in hepatic dysfunction on hospital length of stay	60 days	Avoid hepatotoxic drugs;basic disease approach The effectiveness of the interventions on organic disfunction will be evaluated through the formula: Number of patients with hepatic dysfunction and effective intervention / Number of patients with hepatic dysfunction X 100
Impact of standardized interventions in hemodinamic dysfuction on ventilator-free days	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. The effectiveness of the interventions on organic disfunction will be evaluated through the formula: Number of patients with hemodinamic dysfunction and effective intervention / Number of patients with hemodinamic dysfunction X 100
Impact of standardized interventions in neurologic dysfunction on ventilator-free days	28 days	Image: cranial CT; Electroencephalografic monitoring and RASS Score between -1 and +1 The effectiveness of the interventions on organic disfunction will be evaluated through the formula: Number of patients with neurologic dysfunction and effective intervention / Number of patients with neurologic dysfunction X 100
Impact of standardized interventions in hepatic dysfunction on ventilator-free days	28 days	Avoid hepatotoxic drugs;basic disease approach The effectiveness of the interventions on organic disfunction will be evaluated through the formula: Number of patients with hepatic dysfunction and effective intervention / Number of patients with hepatic dysfunction X 100
Impact of standardized interventions in respiratory dysfunction on hospital length of stay	60 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. The effectiveness of the interventions on organic disfunction will be evaluated through the formula: Number of patients with respiratory dysfunction and effective intervention / Number of patients with respiratory dysfunction X 100
Impact of standardized interventions in hepatic dysfunction on vasopressor-free days	28 days	Avoid hepatotoxic drugs;basic disease approach The effectiveness of the interventions on organic disfunction will be evaluated through the formula: Number of patients with hepatic dysfunction and effective intervention / Number of patients with hepatic dysfunction X 100
Impact of standardized interventions in respiratory dysfunction on ventilator-free days	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. The effectiveness of the interventions on organic disfunction will be evaluated through the formula: Number of patients with respiratory dysfunction and effective intervention / Number of patients with respiratory dysfunction X 100
Impact of standardized interventions in hematologic dysfunction on ventilator-free days	28 days	Basic disease approach; avoid drugs that interfere with coagulation; Platelet transfusion in case of hemohhage; DDAVP when indicated. The effectiveness of the interventions on organic disfunction will be evaluated through the formula: Number of patients with hematologic dysfunction and effective intervention / Number of patients with hematologic dysfunction X 100
Impact of standardized interventions in renal dysfunction on hospital length of stay	60 days	Avoid nephotoxic drugs; Mantain mean arterial blood pressure \> 65 mmHg The effectiveness of the interventions on organic disfunction will be evaluated through the formula: Number of patients with renal dysfunction and effective intervention / Number of patients with renal dysfunction X 100
Impact of standardized interventions in neurologic dysfunction on hospital length of stay	60 days	Image: cranial CT; Electroencephalografic monitoring and RASS Score between -1 and +1 The effectiveness of the interventions on organic disfunction will be evaluated through the formula: Number of patients with neurologic dysfunction and effective intervention / Number of patients with neurologic dysfunction X 100

Trial Locations

Locations (1)

Hospital Sao Domingos; 🇧🇷 Sao Luis, MA, Brazil