Terlipressin Alone Versus the Standard Therapy With Catecholamines for Hepatic Patients With Septic Shock- Prospective Single Center Randomized Controlled Study.
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Hemodynamic stability & optimization; mean blood pressure more than or equal 65mmHg
研究概览
简要总结
The purpose of this study is to evaluate the use of terlipressin compared to standard regimen in hepatic patients with septic shock. Another aim is to compare the mortality rate & the effects on renal functions in both groups.
详细描述
Study type:
This is a single center, prospective randomized controlled study.
Inclusion criteria:
The subjects are adults aged between 18 & 70 years who will be admitted to the intensive care unit (ICU) of National Hepatology & Tropical Medicine Research Institute (NHTMRI).
All patients that will be included in the study should have septic shock diagnosed by having sepsis with an underlying circulatory and cellular/metabolic abnormality
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
patients will be randomly assigned in 1:1 manner
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged between 18 & 70years who will be admitted to the intensive care unit (ICU) of National Hepatology & Tropical Medicine Research Institute (NHTMRI).
- •All patients that will be included in the study should have septic shock diagnosed by having sepsis with an underlying circulatory and cellular/metabolic abnormality.
排除标准
- •Patients will be excluded if they are pregnant, have uncontrolled hypertension, ischemic skin necrosis, present or suspected coronary artery disease, present or suspected acute mesenteric ischemia, or peripheral vascular diseases (e.g. Raynaud's syndrome or related diseases) and hypersensitivity to Terlipressin.
研究组 & 干预措施
nor-epinephrine+/- epinephrine infusion
Intravenous infusion of Nor-epinephrine in an initial dose of 0.01µg/kg/min. which can be increased every 15-30 minutes to maximum 3µg/kg/min. ± intravenous infusion of epinephrine with an initial dose 0.05µg/kg/min. & can be titrated every 15-30 minutes up to 2µg/Kg/min.
The end point is to achieve mean arterial pressure ≥ 65 mmHg & normalized lactate ≤ 2 mmol/L or lactate clearance ≥ 10% within 6 hours.
Patients will be followed for 48 hours.
干预措施: Experimental (Drug)
Terlipressin infusion
Intravenous infusion of terlipressin by rate 1-2µg/kg/min. The end point is to achieve mean arterial pressure ≥ 65 mmHg & normalized lactate ≤ 2mmol/L or lactate clearance ≥ 10% within 6 hours.
Patients will be followed for 48 hours.
干预措施: Experimental (Drug)
结局指标
主要结局
Hemodynamic stability & optimization; mean blood pressure more than or equal 65mmHg
时间窗: 48hours up to 7days
how fast hemodynamic stability will be achieved in each arm of the study
mortality
时间窗: 28 days
28-day mortality will be followed by phone calls to the patient or one of his/her first degree relatives
Hemodynamic stability & optimization; mean blood pressure
时间窗: 48hours up to 7days
for how long hemodynamic stability will be maintained
Hemodynamic stability & optimization, lactate clearance to be 2mmol/L
时间窗: 48hours up to 7days
how fast it will be achieved
次要结局
未报告次要终点
研究者
Eman Desoki
Fellow of intensive care medicine, NHTMRI
National Hepatology & Tropical Medicine Research Institute