NCT00344916已完成1 期
NO-Synthesis in Patients With Liver Cirrhosis: Effect of L-NMMA on Renal Hemodynamics, Sodium Excretion and Plasma Levels of Vasoactive Hormones
Regional Hospital Holstebro0 个研究点目标入组 30 人开始时间: 2006年6月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
Phase 1 study of the effects of nitric oxide inhibition with L-NMMA in patients with liver cirrhosis and healthy controls. It is hypothesized that nitric oxide availability is increased in liver cirrhosis.
详细描述
In a randomized, placebo controlled design the acute effects of Ng-monomethyl-L-arginine are studied on:
- renal hemodynamics (GFR and RPF)
- blood pressure and heart rate
- lithium clearance
- plasma levels of vasoactive hormones
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy controls
- •Age 20 to 60 years
- •Both men and women
- •Weight below 100 kg
- •Normal clinical examination and laboratory screening
- •Fertile women only if using contraception
- •Informed consent according to the regulations of the local ethics committee
- •Liver cirrhosis
- •Biopsy verified liver cirrhosis or clinical and laboratory signs of liver cirrhosis including hypoalbuminaemia, increased prothrombin time in combination with esophagusvarices or ascites
- •P-creatinine < 250 µmol/L
- •Age 20-60 years
- •Both men and women
- •Fertile women only if using contraception
- •Body weight below 100 kg
- •Informed consent according to the regulations of the local ethics committee
排除标准
- •Healthy controls
- •History or clinical evidence of diseases of the heart and blood vessels, kidneys, liver and pancreas, endocrine organs, lungs, neoplastic disease, myocardial infarction or cerebrovascular insult as evaluated by clinical examination and laboratory screening
- •Current medication
- •Drugs or alcohol abuse
- •Pregnancy
- •Previously within one year received more than 0.2 mSV radioactive treatment or diagnostic substances
- •Donation of blood less than 1 month before the experiments
- •Liver cirrhosis
- •Apart from liver cirrhosis no history of diseases of the heart and blood vessels, endocrine organs, lungs, myocardial infarction, cerebrovascular insult or neoplastic disease.
- •Drugs or alcohol abuse
- •Pregnancy
- •Previously within one year received more than 0.2 mSV radioactive treatment or diagnostic substances
研究者
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