Impact of Interventions on Admission SOFA Score on Clinical Outcomes of Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 849
- 试验地点
- 1
- 主要终点
- Impact of standardized interventions in respiratory dysfunction on 48-hour delta SOFA with evaluation of the effectiveness of the interventions performed.
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged above 18 years,
- •Lenght of ICU stay of at least 3 days.
排除标准
- •Pregnant patients
- •End-of-life
- •Patients readmitted to the ICU in the same hospitalization
结局指标
主要结局
Impact of standardized interventions in respiratory dysfunction on 48-hour delta SOFA with evaluation of the effectiveness of the interventions performed.
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- 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 in respiratory dysfunction on vasopressor-free days(28 days)
- Impact of standardized interventions in neurologic dysfunction on vasopressor-free days(28 days)
- Impact of standardized interventions in hematologic dysfunction on vasopressor-free days(28 days)
- Impact of standardized interventions in respiratory dysfunction on ICU length of stay(28 days)
- Impact of standardized interventions iin renal dysfunction on ICU length of stay(28 days)
- Impact of standardized interventions in hemodinamic dysfuction on vasopressor-free days(28 days)
- Impact of standardized interventions in hepatic dysfunction on ICU length of stay(28 days)
- Impact of standardized interventions iin renal dysfunction on vasopressor-free days(28 days)
- Impact of standardized interventions iin renal dysfunction on ventilator-free days(28 days)
- Impact of standardized interventions in hemodinamic dysfuction on hospital length of stay(60 days)
- Impact of standardized interventions in hematologic dysfunction on hospital length of stay(60 days)
- Impact of standardized interventions in hepatic dysfunction on hospital length of stay(60 days)
- Impact of standardized interventions in hemodinamic dysfuction on ventilator-free days(28 days)
- Impact of standardized interventions in neurologic dysfunction on ventilator-free days(28 days)
- Impact of standardized interventions in hepatic dysfunction on ventilator-free days(28 days)
- Impact of standardized interventions in respiratory dysfunction on hospital length of stay(60 days)
- Impact of standardized interventions in hepatic dysfunction on vasopressor-free days(28 days)
- Impact of standardized interventions in respiratory dysfunction on ventilator-free days(28 days)
- Impact of standardized interventions in hematologic dysfunction on ventilator-free days(28 days)
- Impact of standardized interventions in renal dysfunction on hospital length of stay(60 days)
- Impact of standardized interventions in neurologic dysfunction on hospital length of stay(60 days)
研究者
José Raimundo Araujo de Azevedo
ICU Assistant Physician
Hospital Sao Domingos