MUNI-SEP TRIAL-The Role of Ulinastatin in Preventing Severe Sepsis and Consequent Morbidities and Mortality; A Randomized Clinical Trial in Pakistan.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Effect on in-hospital mortality
研究概览
简要总结
The study will enhance the theory in the frame of reference on the efficacy of Ulinastatin while managing sepsis and subsequent morbidity and mortality. Moreover, the present study will explore Ulinastatin's prophylactic role in progression of multiple organ dysfunctions. Furthermore, the study will have the clinical implications in predicting the ICU admitted patient's stay and related cost in the context of new drug. Current researches will explore the new dimensions in Pakistan's healthcare facilities, paving the way of future academics to analyze it in order to enhance healthcare outcomes.
详细描述
The current study is a randomised clinical trial with the aim of exploring the following objectives in the context of Pakistan:
- To determine the efficacy of Ulinastatin in preventing the progression of Sepsis to Severe Sepsis and septic shock.
- To assess the role of Ulinastatin in preventing the onset of MODS in sepsis-induced patients.
- To investigate the impact of Ulinastatin on sepsis associated mortality and morbidity.
- To explore the role of Ulinastatin in reducing ICU stays and associated costs in defined patients.
- To provides a condensed basis to understand ULINASTATIN as a sepsis management drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 or <60
- •Sepsis, and severe sepsis, as defined in operational definitions
- •Patients voluntarily agreed to participate in the study after informed consent
排除标准
- •Fulminant hepatic failure
- •Acute cerebrovascular accidents
- •Acute poisoning
- •Chronic Kidney Disease stage 5
- •Diagnosed case of immune thrombocytopenia
- •Low output cardiac failure, with left ventricular ejection fraction <20%
- •Advance chronic obstructive pulmonary disease on long term oxygen therapy
- •Lactation or pregnancy
研究组 & 干预措施
Active Intervention Arm
This group will receive Nine MiU Ulinastatin in three divided doses 8 hourly
干预措施: Ulinastatin (Drug)
结局指标
主要结局
Effect on in-hospital mortality
时间窗: During first 48 hours of hospital stay after enrollment
To investigate the impact of Ulinastatin on sepsis associated mortality.
Effect on 28 days mortality
时间窗: During the 28 days of enrollment
To investigate the impact of Ulinastatin on sepsis associated mortality.
Effect on 7 days mortality
时间窗: During the 7 days of enrollment
To investigate the impact of Ulinastatin on sepsis associated mortality.
Effect on 14 days mortality
时间窗: During the 14 days of enrollment
To investigate the impact of Ulinastatin on sepsis associated mortality.
Prevention of MOD's in patients with sepsis
时间窗: Day 5 of enrollment
To assess the role of Ulinastatin in preventing the onset of MODS in sepsis-induced patients. Sepsis is defnied as evidence of infection (positive culture of blood, Urine, Tracheal) or suspected infection (by a physician) plus 2 out of 4 criteria's of SIRS. MODS is presence of two or more organ dysfunction with scoring ≥2 of each organ as per Sequential Organ Failure Assessment (SOFA) score.
次要结局
- Number of days on mechanical ventilation(Up to 28 days after enrollment)
- Prevention of Septic Shock in patients admitted with Sepsis(Up to 28 days after enrollment)
- Number of days in ICU(Up to 28 days after enrollment)
- Prevention of Severe Sepsis in patients admitted with Sepsis(Up to 28 days after enrollment)
研究者
ZA
Associate Professor
Jinnah Postgraduate Medical Centre