跳至主要内容
临床试验/DRKS00016797
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

发起方
niversitätsklinikum Hamburg-Eppendorf

相似试验