Critically Ill PatientsNCT05790915
Impact of Interventions on Admission SOFA Score on Clinical Outcomes of Critically Ill Patients
An observational study of Critically Ill Patients, run by Hospital Sao Domingos at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill Patients
- What is being tested?
- Standardized interventions
- How many people
- 849 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2023to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients aged above 18 years,
- Lenght of ICU stay of at least 3 days.
Who cannot join
- Pregnant patients
- End-of-life
- Patients readmitted to the ICU in the same hospitalization
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- 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.
- Conditions
- Critically Ill Patients
- Being tested
- Standardized interventions
- Keywords
- SOFA Score, Delta SOFA, Critically ill patients, Interventions, Outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized interventionsCombination product
Standardized interventions according organ dysfunction
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Combination Product: Standardized interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 48 hour
Secondary outcomes (24)
Impact of standardized interventions in respiratory dysfunction on ICU length of stay
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
Measured: 28 days
Impact of standardized interventions in hemodinamic dysfuction on ICU length of stay
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
Measured: 28 days
Impact of standardized interventions in neurologic dysfunction on ICU length of stay
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
Measured: 28 days
Impact of standardized interventions in hematologic dysfunction on ICU length of stay
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
Measured: 28 days
Impact of standardized interventions iin renal dysfunction on ICU length of stay
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
Measured: 28 days
Impact of standardized interventions in hepatic dysfunction on ICU length of stay
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
Measured: 28 days
Impact of standardized interventions in respiratory dysfunction on vasopressor-free 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
Measured: 28 days
Impact of standardized interventions in hemodinamic dysfuction on vasopressor-free 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
Measured: 28 days
Impact of standardized interventions in neurologic dysfunction on vasopressor-free 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
Measured: 28 days
Impact of standardized interventions in hematologic dysfunction on vasopressor-free 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
Measured: 28 days
Impact of standardized interventions iin renal dysfunction on vasopressor-free 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
Measured: 28 days
Impact of standardized interventions in hepatic dysfunction on vasopressor-free 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
Measured: 28 days
Impact of standardized interventions in respiratory dysfunction on ventilator-free 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
Measured: 28 days
Impact of standardized interventions in hemodinamic dysfuction on ventilator-free 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
Measured: 28 days
Impact of standardized interventions in neurologic dysfunction on ventilator-free 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
Measured: 28 days
Impact of standardized interventions in hematologic dysfunction on ventilator-free 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
Measured: 28 days
Impact of standardized interventions iin renal dysfunction on ventilator-free 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
Measured: 28 days
Impact of standardized interventions in hepatic dysfunction on ventilator-free 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
Measured: 28 days
Impact of standardized interventions in respiratory dysfunction on hospital length of stay
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
Measured: 60 days
Impact of standardized interventions in hemodinamic dysfuction on hospital length of stay
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
Measured: 60 days
Impact of standardized interventions in neurologic dysfunction on hospital length of stay
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
Measured: 60 days
Impact of standardized interventions in hematologic dysfunction on hospital length of stay
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
Measured: 60 days
Impact of standardized interventions in renal dysfunction on hospital length of stay
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
Measured: 60 days
Impact of standardized interventions in hepatic dysfunction on hospital length of stay
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
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start1 Aug 2023
- Primary completion30 Jan 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Critically Ill PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 849 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Sao Domingos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Raimundo Araujo de Azevedo, Hospital Sao Domingos
- Investigators
- JOSE R AZEVEDO, MD, PhD, Study director, Hospital Sao DomingosBARBARA L RIBEIRO, MD, Principal investigator, Hospital Sao Domingos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790915
- Sponsor's protocol ID
- HSD 2023 1
- Status last verified
- Apr 2024
- First submitted
- 21 Feb 2023
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20036543Bone 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.
PubMed 1600757Moreno 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.
PubMed 10470572Vincent 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.
PubMed 8844239Jones 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.
PubMed 19325482de 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.
PubMed 25241933Soo 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.
PubMed 31122276de 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.
PubMed 28231816
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Interventions on Admission SOFA Score on Clinical Outcomes of Critically Ill Patients
- ClinicalTrials.gov ID
- NCT05790915
- Acronym / sponsor ID
- HSD 2023 1
- Conditions
- Critically Ill Patients
- Keywords
- SOFA Score, Delta SOFA, Critically ill patients, Interventions, Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 849 participants (actual)
- Lead sponsor
- Hospital Sao DomingosUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Patients with SOFA score < 2 at admission. No intervention |
| Group 2 | – | Combination Product: Standardized interventionsPatients 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 | – | Combination Product: Standardized interventionsPatients 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients aged above 18 years,
- Lenght of ICU stay of at least 3 days.
Key exclusion criteria (3 listed)
- Pregnant patients
- End-of-life
- Patients readmitted to the ICU in the same hospitalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized interventionsStandardized interventions according organ dysfunction | Combination product | Group 2, Group 3 |
Primary outcome
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
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
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
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
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
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
24 secondary outcomes
Impact of standardized interventions in respiratory dysfunction on ICU length of stay
Time frame: 28 days
Impact of standardized interventions in hemodinamic dysfuction on ICU length of stay
Time frame: 28 days
Impact of standardized interventions in neurologic dysfunction on ICU length of stay
Time frame: 28 days
Impact of standardized interventions in hematologic dysfunction on ICU length of stay
Time frame: 28 days
Impact of standardized interventions iin renal dysfunction on ICU length of stay
Time frame: 28 days
Impact of standardized interventions in hepatic dysfunction on ICU length of stay
Time frame: 28 days
Impact of standardized interventions in respiratory dysfunction on vasopressor-free days
Time frame: 28 days
Impact of standardized interventions in hemodinamic dysfuction on vasopressor-free days
Time frame: 28 days
Impact of standardized interventions in neurologic dysfunction on vasopressor-free days
Time frame: 28 days
Impact of standardized interventions in hematologic dysfunction on vasopressor-free days
Time frame: 28 days
Impact of standardized interventions iin renal dysfunction on vasopressor-free days
Time frame: 28 days
Impact of standardized interventions in hepatic dysfunction on vasopressor-free days
Time frame: 28 days
Impact of standardized interventions in respiratory dysfunction on ventilator-free days
Time frame: 28 days
Impact of standardized interventions in hemodinamic dysfuction on ventilator-free days
Time frame: 28 days
Impact of standardized interventions in neurologic dysfunction on ventilator-free days
Time frame: 28 days
Impact of standardized interventions in hematologic dysfunction on ventilator-free days
Time frame: 28 days
Impact of standardized interventions iin renal dysfunction on ventilator-free days
Time frame: 28 days
Impact of standardized interventions in hepatic dysfunction on ventilator-free days
Time frame: 28 days
Impact of standardized interventions in respiratory dysfunction on hospital length of stay
Time frame: 60 days
Impact of standardized interventions in hemodinamic dysfuction on hospital length of stay
Time frame: 60 days
Impact of standardized interventions in neurologic dysfunction on hospital length of stay
Time frame: 60 days
Impact of standardized interventions in hematologic dysfunction on hospital length of stay
Time frame: 60 days
Impact of standardized interventions in renal dysfunction on hospital length of stay
Time frame: 60 days
Impact of standardized interventions in hepatic dysfunction on hospital length of stay
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Background: PubMed 20036543Anami 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.
- Results publication: PubMed 1600757Bone 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.
- Results publication: PubMed 10470572Moreno 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.
- Results publication: PubMed 8844239Vincent 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.
- Results publication: PubMed 19325482Jones 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.
- Results publication: PubMed 25241933de 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.
- Results publication: PubMed 31122276Soo 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.
- Results publication: PubMed 28231816de 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.
- Individual participant dataSharing planned: No
Related trials for Critically Ill Patients
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
Not yet recruitingObservational study
Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring: Value and Accuracy in Hemodynamic Care
Sepsis, Circulatory Instability
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JOSE R AZEVEDO, MD, PhD study director
Hospital Sao Domingos
BARBARA L RIBEIRO, MD principal investigator
Hospital Sao Domingos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill Patients, run by Hospital Sao Domingos at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05790915, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.