DRKS00016797已完成未知
Effect of oral supplementation with the amino acid L-arginine on peri- operative cardiovascular risk in non-selected patients – Role of pre-operative determination of plasma ADMA levels for therapeutic stratification. - LAOS Trial
niversitätsklinikum Hamburg-Eppendorf0 个研究点目标入组 269 人开始时间: 2019年3月5日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 269
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 30 Years 至 75 Years(—)
- 性别
- All
入选标准
- •male and female subjects aged between 30 and 75 years;
- •scheduled major thoracic (non-cardiac), abdominal, or two cavity surgery;
- •ASA risk class II- IV;
- •efficient birth control for women in child-bearing age;
- •signed written informed consent form.
排除标准
- •participation in a clinical study within the last 3 months before inclusion into the present study;
- •high allergic tendency in the medical history at the investigators discretion;
- •patients with known diabetic retinopathy;
- •previous abuse of drugs or alcohol;
- •pregnancy or nursing;
- •any severe consuming disease (malignant or non-malignant) that reduces the pa-tient’s life expectancy to a level which makes it uncertain that the patient would survive the 30 day period even without surgery;
- •any somatic or psychic disease that may hamper participation in the study or compliance;
- •active liver disease or hepatic failure (serum AST or ALT >1.5-fold above the up-per limit of the normal range);
- •severe renal failure (calculated creatinine clearance < 30 ml/min [Cockroft-Gault formula]), nephrotic syndrome or dysproteinemia;
- •previous intolerance of L-arginine or L-citrulline.
研究者
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