ISRCTN49482187
已完成
不适用
A pilot, double-blind, randomised, placebo-controlled, exploratory study to investigate the safety and effect of calf intestinal Alkaline Phosphatase in patients with SEPsis
AM-Pharma B.V. (Netherlands)0 个研究点目标入组 32 人2005年12月20日
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Sepsis
- 发起方
- AM-Pharma B.V. (Netherlands)
- 入组人数
- 32
- 状态
- 已完成
- 最后更新
- 11年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Patients greater than or equal to 18 years and less than or equal to 80 years
- •2\. Proven or suspected infection
- •3\. Two out of four SIRS criteria of systemic inflammation, existing for less than 24 hours after admission in the intensive care unit:
- •a. core temperature greater than or equal to 38 or less than or equal to 36°Celsius
- •b. heart rate greater than of equal to 90 beats/min (unless the patient has a medical condition known to increase heart rate or is receiving treatment that would prevent tachycardia)
- •c. respiratory rate greater than or equal to 20 breaths/min, an arterial carbon dioxide pressure (PaCO2\) less than or equal to 32 mmHg or the use of mechanical ventilation for an acute respiratory process
- •d. white\-cell count greater than or equal to 12,000/mm^3 or less than or equal to 4,000/mm^3 or a differential count showing more than 10% immature neutrophils
- •4\. Acute onset of end\-organ dysfunction in the preceding 12 hours unrelated to the primary septic focus and not explained by any underlying chronic disease as indicated by one or more of the following:
- •a. sustained hypotension or organ dysfunction that is the result of sepsis and not the patient?s underlying disease or treatment, as evidenced by one or more of the following criteria for less than 12 hours:
- •i. systolic blood pressure less than or equal to 90 mmHg or mean arterial pressure less than or equal to 70 mmHg for at least one hour (by two or more measurements) despite adequate fluid intake, or
排除标准
- •1\. Pregnant or lactating women
- •2\. Known Human Immunodeficiency Virus (HIV) seropositive patients
- •3\. Patients receiving immunosuppressive therapy or high doses of glucocorticosteroids (defined as more than 1 mg/kg/day) equivalent to prednisone 1 mg/kg/day
- •4\. Patients expected to have rapidly fatal disease within 24 hours
- •5\. Known confirmed gram\-positive sepsis
- •6\. Known confirmed fungal sepsis
- •7\. Chronic renal failure requiring haemodialysis or peritoneal dialysis
- •8\. Acute pancreatitis with no established source of infection
- •9\. Patients not expected to survive for 28 days due to other medical conditions such as end\-stage neoplasm or other diseases
- •10\. Participation in another investigational study within 90 days prior to start of the study which might interfere with this study
结局指标
主要结局
未指定
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