Skip to main content
OpenTrials
Completed

NCT Number: NCT05790915

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Critically Ill Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Sao Domingos

São Luís, Maranhão, 65060-000, Brazil

About this study

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

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Standardized interventions

Combination Product

Standardized interventions according organ dysfunction

Primary outcomes

  1. Impact of standardized interventions in respiratory dysfunction on 48-hour delta SOFA with evaluation of the effectiveness of the interventions performed.

    Time frame: 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

  2. Impact of standardized interventions in hemodinamic dysfunction on 48-hour delta SOFA

    Time frame: 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

  3. Impact of standardized interventions in neurologic dysfunction on 48-hour delta SOFA

    Time frame: 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

  4. Impact of standardized interventions in hematologic dysfunction on 48-hour delta SOFA

    Time frame: 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

  5. Impact of standardized interventions iin renal dysfunction on 48-hour delta SOFA

    Time frame: 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

  6. Impact of standardized interventions in hepatic dysfunction on 48-hour delta SOFA

    Time frame: 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

Secondary outcomes

  1. Impact of standardized interventions in respiratory dysfunction on ICU length of stay

    Time frame: 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

  2. Impact of standardized interventions in hemodinamic dysfuction on ICU length of stay

    Time frame: 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

  3. Impact of standardized interventions in neurologic dysfunction on ICU length of stay

    Time frame: 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

  4. Impact of standardized interventions in hematologic dysfunction on ICU length of stay

    Time frame: 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

  5. Impact of standardized interventions iin renal dysfunction on ICU length of stay

    Time frame: 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

  6. Impact of standardized interventions in hepatic dysfunction on ICU length of stay

    Time frame: 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

  7. Impact of standardized interventions in respiratory dysfunction on vasopressor-free days

    Time frame: 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

  8. Impact of standardized interventions in hemodinamic dysfuction on vasopressor-free days

    Time frame: 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

  9. Impact of standardized interventions in neurologic dysfunction on vasopressor-free days

    Time frame: 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

  10. Impact of standardized interventions in hematologic dysfunction on vasopressor-free days

    Time frame: 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

  11. Impact of standardized interventions iin renal dysfunction on vasopressor-free days

    Time frame: 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

  12. Impact of standardized interventions in hepatic dysfunction on vasopressor-free days

    Time frame: 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

  13. Impact of standardized interventions in respiratory dysfunction on ventilator-free days

    Time frame: 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

  14. Impact of standardized interventions in hemodinamic dysfuction on ventilator-free days

    Time frame: 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

  15. Impact of standardized interventions in neurologic dysfunction on ventilator-free days

    Time frame: 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

  16. Impact of standardized interventions in hematologic dysfunction on ventilator-free days

    Time frame: 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

  17. Impact of standardized interventions iin renal dysfunction on ventilator-free days

    Time frame: 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

  18. Impact of standardized interventions in hepatic dysfunction on ventilator-free days

    Time frame: 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

  19. Impact of standardized interventions in respiratory dysfunction on hospital length of stay

    Time frame: 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

  20. Impact of standardized interventions in hemodinamic dysfuction on hospital length of stay

    Time frame: 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

  21. Impact of standardized interventions in neurologic dysfunction on hospital length of stay

    Time frame: 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

  22. Impact of standardized interventions in hematologic dysfunction on hospital length of stay

    Time frame: 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

  23. Impact of standardized interventions in renal dysfunction on hospital length of stay

    Time frame: 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

  24. Impact of standardized interventions in hepatic dysfunction on hospital length of stay

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospital Sao Domingos

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 30, 2023
Registry last updated
May 21, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.