Impact of Interventions on Admission SOFA Score on Clinical Outcomes of Critically Ill Patients
NCT ID: NCT05790915
Last Updated: 2024-05-21
Study Results
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Basic Information
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COMPLETED
849 participants
OBSERVATIONAL
2023-08-01
2024-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Group 1
Patients with SOFA score \< 2 at admission. No intervention
No interventions assigned to this group
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)
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)
Standardized interventions
Standardized interventions according organ dysfunction
Interventions
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Standardized interventions
Standardized interventions according organ dysfunction
Eligibility Criteria
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Inclusion Criteria
* Lenght of ICU stay of at least 3 days.
Exclusion Criteria
* End-of-life
* Patients readmitted to the ICU in the same hospitalization
18 Years
ALL
No
Sponsors
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Hospital Sao Domingos
OTHER
Responsible Party
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José Raimundo Araujo de Azevedo
ICU Assistant Physician
Principal Investigators
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JOSE R AZEVEDO, MD, PhD
Role: STUDY_DIRECTOR
Hospital Sao Domingos
BARBARA L RIBEIRO, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Sao Domingos
Locations
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Hospital Sao Domingos
São Luís, Maranhão, Brazil
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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HSD 2023 1
Identifier Type: -
Identifier Source: org_study_id
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