EUCTR2007-001831-73-DE进行中（未招募）不适用
REducing Deaths due to OXidative Stress The REDOXS© Study A 2×2 factorial randomized trial of glutamine and antioxidant supplementation in critically ill patients - REDOXS©
Kingston General Hospital, Queen's University of Kingston0 个研究点目标入组 1,200 人开始时间: 2008年10月13日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,200
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 must meet ALL inclusion criterias:
- •1. Signed informed consent has been obtained from the patient or his/her legally acceptable representative
- •2. Mechanically ventilated adult patients (>18 years old) admitted to ICU will be considered eligible if they have 2 or more of the following organ failures related to their acute illness:
- •- A PaO2/FiO2 ratio of <300;
- •- Clinical evidence of hypoperfusion defined as the need for vasopressor agents (norepinephrine, epinephrine, vasopressin, > 5 µg/kg/min of dopamine, or > 50 µg/min phenylephrine) for greater than or equal to 2 hours;
- •- In patients without known renal disease, renal dysfunction defined as a serum creatinine >171 µmol/L or a urine out-put of less than 500 ml/last 24 hours (or 80 ml/last 4 hours if a 24 hour period of observation not available). In pa-tients with acute on chronic renal failure (pre-dialysis), an absolute increase of > 80 µmol/L from baseline or pre-admission creatinine or a urine output of < 500 ml/last 24 hours (or 80 ml/last 4 hours) will be required;
- •- A platelet count of < 50 x109/l.
- •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
- •Patients will be excluded for any of the following reasons:
- •1. > 24 hours from admission to ICU
- •2. Patients who are moribund (not expected to be in ICU for more than 48 hours due to imminent death)
- •3. A lack of commitment to full aggressive care (anticipated withholding or withdrawing treatments in the first week)
- •4. Absolute contraindication to enteral nutrients (e.g., GI perforation, obstruction or no GI tract access for any reason)
- •5. Patients with severe acquired brain injury
- •a)Significant head trauma (defined as an injury in the opinion of the investigator,
- •that represents a severe, disabling, or fatal brain injury)
- •b)Grade 4 or 5 subarachnoid haemorrhage
- •c) Stroke resulting in coma and intubation
- •d) Post-cardiac arrest with suspected significant an-oxic brain injury
- •6. Seizure disorder requiring anticonvulsant medication
- •7. Cirrhosis - Child’s class C liver disease
- •8. Metastatic cancer or Stage IV Lymphoma with life expec-tancy < 6 months
- •9. Routine elective cardiac surgery (patients with complicated peri-operative course requiring pressors, IABP, ventricular assist devices can be included)
- •10. Patients with primary admission diagnosis of burns (> 30% body surface area
- •11. Known or suspected hypersensitivity to component(s) of study medication
- •12. Hereditary metabolic disorder in regards to component(s) of study medication
- •13. Weight less than 50 kg or greater than 200 kg
- •14. Pregnant patients or lactating with the intent to breastfeed. Females of child-bearing potential should have a negative urine or serum pregnancy test within 24 h prior to administration of study medication
- •15. Previous randomization in this study
- •16. Enrollment in a related ICU interventional study
研究者
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