Effects of Voluven on Hemodynamics and Tolerability of Enteral Nutrition in Patients With Severe Sepsis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 24
- 主要终点
- Amount of Study Drug Required to Achieve Initial Hemodynamic Stabilization
研究概览
简要总结
The rapidity and the quality of fluid resuscitation in patients with severe sepsis are important factors for the prevention of secondary multi-organ failure. Vascular filling may also have an impact on tolerability of enteral nutrition. The earliness and quantity of calories provided by enteral nutrition may have an impact on morbidity and mortality. This study will asses the effects of volume expansion on hemodynamics and tolerability of enteral nutrition in patients with severe sepsis. A Data Monitoring Committee will review regularly safety data of the study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Severe sepsis
- •Requirement for fluid resuscitation
排除标准
- •serum creatinine > 300µmol/L
- •Chronic renal failure
- •Anuria lasting more than 4 hours
- •Requirement for renal support
研究组 & 干预措施
Voluven® Arm
干预措施: 6 % Hydroxyethylstarch 130/0.4 = "Voluven®" (Drug)
0.9 % NaCl
干预措施: 0.9 % NaCl (Drug)
结局指标
主要结局
Amount of Study Drug Required to Achieve Initial Hemodynamic Stabilization
时间窗: until hemodynamic stabilization (up to 48 hours)
Initial hemodynamic stabilization (HDS) was defined as normalization of mean arterial pressure (MAP) and at least two of the three parameters central venous pressure (CVP), urine output and central venous oxygen saturation and maintaining this normalization over a period of four hours, with no increase in the infusion of vasopressors, or ionotropic therapy and with no more than 1 L of additional study drug administration within these four hours.
次要结局
- Time From Start of Fluid Resuscitation With Study Drug to the Initial Hemodynamic Stabilization(until hemodynamic stabilization (up to 48 hours))
- Quantity of Study Drug in 4 Days(4 days)
- Time From Start of Study Drug to Start of Enteral Nutrition in the Subgroup of Patients Who Received Enteral Nutrition(Until start of enteral nutrition (up to 48 hours))
- Time From Start of Fluid Resuscitation With Study Drug to Start of Enteral Nutrition After Hemodynamic Stabilization(up to 48 hours)
- Total Amount of Enteral Calories During the First Seven Days of Enteral Nutrition(7 days)
- Length of Stay in the Intensive Care Unit (ICU)(Until discharge from ICU (up to day 90))
- Length of Stay in the ICU(Until discharge from ICU (up to Day 90))
- Length of Stay in the Hospital(Until discharge from hospital (up to day 90))
- Area Under the Curve (AUC) of Sepsis-related Organ Failure Assessment (SOFA) Score Per Day From Screening to Day 4(From Screening to Day 4)