Prospective Randomized Multicenter Study on the Influence of Colloid vs Crystalloid Volume Resuscitation and of Intensive vs Conventional Insulin Therapy on Outcome in Patients With Severe Sepsis and Septic Shock
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 32
- 主要终点
- Mortality (28 day)
研究概览
简要总结
The purpose of this trial is to determine the influence of colloid versus crystalloid volume resuscitation and of intensive vs conventional insulin therapy on morbidity and mortality of patients with severe sepsis and septic shock.
详细描述
Severe sepsis and septic shock have a high mortality. Research has concentrated on adjunctive sepsis therapies; the role of supportive measures is comparatively unclear. In Europe the use of colloids is widespread, but there is no evidence on the role of either crystalloid or colloid volume therapy in sepsis. Recently, a higher incidence of kidney failure in sepsis was reported after administration of colloids.
In critical illness, a significant reduction in mortality was recently achieved by strict glycemic control, however it has to be determined whether this is true and safe for patients with sepsis as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
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 fulfilling the criteria of "severe sepsis" or "septic shock" according to the Society of Critical Care Medicine/American College of Chest Physicians (SCCM/ACCP) definitions not longer than 24 hours before ICU admission or 12 hours after ICU admission
排除标准
- •Age < 18 years
- •Pregnancy
- •Known allergy against hydroxyethyl starch
- •Pre-treatment with > 1000ml hydroxyethyl starch within 24 hours before inclusion
- •Pre-existing kidney failure requiring dialysis or serum creatinine value > 320 mmol/l (3,6 mg/dl)
- •Intracerebral hemorrhage
- •Severe head trauma with edema
- •FiO2 at time of study inclusion > 0,7
- •Heart failure (New York Heart Association [NYHA] IV)
- •Enrolment in another interventional study
- •Immune suppression (cytostatic chemotherapy, steroid therapy, AIDS)
- •Do not resuscitate (DNR) order
结局指标
主要结局
Mortality (28 day)
Morbidity (mean sepsis-related organ failure assessment [SOFA] score during intensive care unit length of stay [ICU LOS])
次要结局
- Frequency of acute kidney failure
- Time until hemodynamic stabilization
- Frequency of therapy with vasopressors (in days)
- Course of SOFA sub-scores
- Frequency of hemorrhages under hydroxyethyl starch (HES) therapy
- Frequency of hypoglycemia under intensive insulin therapy
- Frequency of critical illness polyneuropathy (CIP)
- 90 day Mortality