Basel Study for Evaluation of Starch (130;0.4) Infusion in Septic Patients: BaSES (130;0.4) Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 231
- 试验地点
- 2
- 主要终点
- Intensive Care length of stay
研究概览
简要总结
Background: In patients with severe sepsis and septic shock early aggressive volume replacement reduced mortality. Standard infusion therapy consists of crystalloid infusions. The role of modern, low molecular weight, starch preparations and their influence on the course of disease is not determined yet.
Hypothesis: The purpose of this study is to determine wether initial infusion therapy with Hydroxyethylstarch and Ringer's lactate reduces in septic patients reduces Intensive Care Unit and hospital length of stay without impairment of renal function
Design: Double-blind, randomized, controlled monocentric study
Setting: Intensive Care Units of a University Hospital
Patients: 240 consecutive patients with sepsis, severe sepsis and septic shock
Intervention: Volume therapy with Ringer's lactate and saline or hydroxy-ethyl starch (MW 130, substitution 0.4) in the first five days of intensive care treatment.
Parameter:
- Intensive Care length of stay
- Hospital length of stay
- Mortality
- Kidney function
Statistics: Mann-Whitney test for non-parametric data like intensive care length of stay. Unpaired t-Test for kidney function parameters.
Study withdrawal: Significant impairment of kidney function parameters in the hydroxy-ethyl starch group
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
- •Patients with suspected or proven infection and 2 of the following 6 criteria:
- •Body temperature <36 or >38.3° celsius
- •Heart rate > 90 beats/min
- •Tachypnea > 20/min or a arterial pCO2 below 4.25 kPa
- •White blood cell count higher than 12.000 or below 4.000 or more than 10% immature forms
- •Systolic blood pressure <90 mmHg or mean arterial pressure < 65 mmHg
- •Altered mental state or oliguria
排除标准
- •Pregnancy
- •Age below 18
- •Allergy against Hydroxyethyl starch
- •Chronic renal insufficiency
研究组 & 干预措施
HES, Septic shock, resuscitation
study group with HES 6%
干预措施: hydroxy-ethyl starch (MW 130; 0.4) vs. normal saline (Drug)
结局指标
主要结局
Intensive Care length of stay
时间窗: time to discharge from the Intensive care unit
Hospital length of stay
时间窗: time to discharge from the hospital
Mortality
时间窗: intesive care, hospital and one year mortality
次要结局
- Kidney function(at intensive care discharge and after one year)
- Lung function(during intensive care)