EUCTR2006-000769-13-BE进行中（未招募）不适用
A double-blind, randomized, placebo-controlled study to investigate the clinical efficacy and safety of two doses of Alkaline Phosphatase administered for three days in patients with severe sepsis and septic shock - AP SEP 02-02
AM-Pharma0 个研究点目标入组 960 人开始时间: 2006年5月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 960
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Clinical defined sepsis:
- •Proven or suspected bacterial infection and
- •Minimally 2 out of 4 SIRS criteria of systemic inflammation positive:
- •Acute onset of at least 1 end-organ dysfunction in the preceding 36 hours:
- •unrelated to the primary septic focus and
- •not explained by any underlying primary chronic disease and
- •as described by at least one of the following 7 underlying conditions:
- •1. Sustained hypotension
- •2. Acute renal failure
- •3. Acute alteration in mental state
- •4. Acute hypoxemic respiratory failure
- •5. Disseminated intravascular coagulopathy (DIC)
- •6. Metabolic acidosis
- •7. Acute hepatic failure
- •at least 18 years
- •Body weight = 125 kg
- •Being committed to - and treated with full intensive care support
- •Written informed consent obtained.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Patients being treated for transplantation of bone marrow, lung, liver, pancreas or other condition.
- •2.Known confirmed gram-positive sepsis.
- •3.Known confirmed fungal sepsis.
- •4.Chronic renal failure requiring hemodialysis or peritoneal dialysis.
- •5.Acute pancreatitis with no established source of infection.
- •6.Patients expected to have rapidly fatal disease within 24 hours .
- •7.Patients not expected to survive for 28 days, due to other medical conditions such as end-stage neoplasm or other diseases.
- •8.Patients being treated with cancer related chemotherapy.
- •9.Participation in another investigational study which clearly and documented interferes with this study, within 30 days prior to start of the study .
- •10.Previous administration of AP.
- •11.Allergy for cow milk.
- •12.Known HIV patients with CD4-count < 50.
- •13.Pregnant and lactating women.
研究者
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