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

NCT05790915 | Completed

• 1 other identifier: HSD 2023 1
• Study Type: observational
• Target: 849
• Locations: 1 country
• Sites: 1

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.

Conditions

Critically Ill Patients

Keywords

SOFA Score; Delta SOFA; Critically ill patients; Interventions; Outcomes

Outcome Measures

Primary Outcomes (6)

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

  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

  48 hours

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

  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

  48 hour

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

  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

  48 hour

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

  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

  48 hour

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

  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

  48 hour

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

  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

  48 hour

Secondary Outcomes (24)

• Impact of standardized interventions in respiratory dysfunction on ICU length of stay

  28 days

• Impact of standardized interventions in hemodinamic dysfuction on ICU length of stay

  28 days

• Impact of standardized interventions in neurologic dysfunction on ICU length of stay

  28 days

• Impact of standardized interventions in hematologic dysfunction on ICU length of stay

  28 days

• Impact of standardized interventions iin renal dysfunction on ICU length of stay

  28 days

Study Arms (3)

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

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

Interventions

Standardized interventions COMBINATION_PRODUCT

Standardized interventions according organ dysfunction

Group 2; Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Sao Domingos: lead

Study Sites (1)

Hospital Sao Domingos

São Luís, Maranhão, 65060-000, Brazil

Location

Related Publications (8)

• Anami EH, Grion CM, Cardoso LT, Kauss IA, Thomazini MC, Zampa HB, Bonametti AM, Matsuo T. Serial evaluation of SOFA score in a Brazilian teaching hospital. Intensive Crit Care Nurs. 2010 Apr;26(2):75-82. doi: 10.1016/j.iccn.2009.10.005. Epub 2009 Dec 29.

  PMID: 20036543 BACKGROUND

• Bone RC, Sibbald WJ, Sprung CL. The ACCP-SCCM consensus conference on sepsis and organ failure. Chest. 1992 Jun;101(6):1481-3. doi: 10.1378/chest.101.6.1481. No abstract available.

  PMID: 1600757 RESULT

• Moreno R, Vincent JL, Matos R, Mendonca A, Cantraine F, Thijs L, Takala J, Sprung C, Antonelli M, Bruining H, Willatts S. The use of maximum SOFA score to quantify organ dysfunction/failure in intensive care. Results of a prospective, multicentre study. Working Group on Sepsis related Problems of the ESICM. Intensive Care Med. 1999 Jul;25(7):686-96. doi: 10.1007/s001340050931.

  PMID: 10470572 RESULT

• Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10. doi: 10.1007/BF01709751. No abstract available.

  PMID: 8844239 RESULT

• Jones AE, Trzeciak S, Kline JA. The Sequential Organ Failure Assessment score for predicting outcome in patients with severe sepsis and evidence of hypoperfusion at the time of emergency department presentation. Crit Care Med. 2009 May;37(5):1649-54. doi: 10.1097/CCM.0b013e31819def97.

  PMID: 19325482 RESULT

• de Azevedo JR, Torres OJ, Beraldi RA, Ribas CA, Malafaia O. Prognostic evaluation of severe sepsis and septic shock: procalcitonin clearance vs Delta Sequential Organ Failure Assessment. J Crit Care. 2015 Feb;30(1):219.e9-12. doi: 10.1016/j.jcrc.2014.08.018. Epub 2014 Sep 10.

  PMID: 25241933 RESULT

• Soo A, Zuege DJ, Fick GH, Niven DJ, Berthiaume LR, Stelfox HT, Doig CJ. Describing organ dysfunction in the intensive care unit: a cohort study of 20,000 patients. Crit Care. 2019 May 23;23(1):186. doi: 10.1186/s13054-019-2459-9.

  PMID: 31122276 RESULT

• de Grooth HJ, Geenen IL, Girbes AR, Vincent JL, Parienti JJ, Oudemans-van Straaten HM. SOFA and mortality endpoints in randomized controlled trials: a systematic review and meta-regression analysis. Crit Care. 2017 Feb 24;21(1):38. doi: 10.1186/s13054-017-1609-1.

  PMID: 28231816 RESULT

Study Officials

• JOSE R AZEVEDO, MD, PhD

  Hospital Sao Domingos

  STUDY DIRECTOR

• BARBARA L RIBEIRO, MD

  Hospital Sao Domingos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ICU Assistant Physician

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 30, 2023
• Study Start: August 1, 2023
• Primary Completion: January 30, 2024
• Study Completion: March 31, 2024
• Last Updated: May 21, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)