EUCTR2007-003866-16-BE进行中（未招募）1 期
A Phase-II, double-blind, randomized, placebo-controlled proof of concept study on the safety and early efficacy of Alkaline Phosphatase in sepsis patients with Renal Failure. - A phase-II db plb-ctrld RCT on Safety and early efficacy of AP in sepsis patients with renal failure
AM-Pharma B.V.0 个研究点目标入组 68 人开始时间: 2009年1月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 68
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
- •Patients =18 years and =80 years.
- •Proven or suspected infection.
- •Two out of four SIRS criteria of systemic inflammation, as follows:
- •Core temperature =38° or =36° Celsius.
- •Heart rate =90 beats/min (unless the patient has a medical condition known to increase heart rate or is receiving treatment that would prevent tachycardia).
- •Respiratory rate =20 breaths/min, a PaCO2 =32mmHg or the use of mechanical ventilation for an acute respiratory process.
- •White-cell count =12,000/mm3 or =4,000/mm3 or a differential count showing >10 percent immature neutrophils.
- •Acute renal failure, defined as - rise in serum creatinine level to =150µmol/L within the previous 48 hours, in the absence of primary underlying renal disease OR - Minimally a stage 1 Kidney Injury according to AKIN criteria: Increase in serum creatinine =26.2 µmol/l (0.3mg/dl) or increase to =150% (=1.5 -fold) from baseline in the previous 48 hours in the absence of primary underlying renal disease and where baseline creatinine is less than 150umol/l OR - minimally a stage 1 Kidney injury according to AKIN Urine Output criteria: Urine Output of = 0.5mg/kg/h for =6 h and following adequate fluid resuscitation when applicable, in the absence of underlying primary renal disease and where baseline creatinine is less than 150umol/l
- •Written informed consent obtained prior to any study intervention.
- •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
- ••Pregnant women or nursing mothers and fecund females who are not on effective contraception (chemical: pill; or mechanical: IUD)
- •Known HIV (sero-positive) patients
- •Patients already on dialysis (RRT) at entry
- •Patients receiving immunosuppressant therapy or on chronic high doses of steroids equivalent to prednisone 1mg/Kg/day
- •Patients expected to have rapidly fatal disease within 24 hours
- •Known confirmed gram-positive sepsis
- •Known confirmed fungal sepsis
- •Acute pancreatitis with no established source of infection
- •Patients not expected to survive for 28 days due to other medical conditions such as end-stage neoplasm or other diseases
- •Participation in another investigational study within 90 days prior to start of the study which might interfere with this study
- •Any previous administration of active study medication.
- •Known allergy for dairy (bovine) products including cow milk.
- •Sepsis without renal failure as defined in the Entry Criteria.
- •History of chronic renal failure or history of persistent creatinine level equal or greater than 150umol/L prior to entry for reasons other than the current sepsis condition.
研究者
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