NCT01311167终止3 期
Prospective Randomized Double Blind Placebo Controlled Intervention Study of the Effect of Dexamethasone on the Sodium Retention in Patients With Liver Cirrhosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 3
- 主要终点
- Daily sodium excretion of sodium in the urine
研究概览
简要总结
Accumulation of salt and water in patients with liver disease (so called liver cirrhosis) is possibly related to the increased effect of steroid hormones on salt reabsorption in the kidney. By reducing overall steroid production with the dexamethasone the accumulation of salt and water could be prevented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with established liver cirrhosis (biopsy or biochemically)
- •hepatorenal syndrome type 1 or 2 (with a serum creatinin >175 umol/l)
- •age between 18 and 75
- •no bacterial infection
- •no cardiovascular or extrahepatic disease (end of life)
- •no structural kidney disease
- •no hepatocellular carcinoma
排除标准
- •age under 15 or over 75
- •treatment with corticosteroids (dexamethasone included)
- •bacterial infection
- •cardiovascular or extrahepatic disease (end of life)
- •structural kidney disease (indicated by hematuria, proteinuria)
- •hepatocellular carcinoma
- •mental disability
研究组 & 干预措施
Dexamethasone
Experimental
干预措施: Dexamethasone (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Daily sodium excretion of sodium in the urine
时间窗: 4 days
次要结局
- Daily potassium excretion(4 days)
- weight reduction(4 days)
- Reduction of doses of diuretics(4 days)
- Reduction of ascites(4 days)
- Reduction of cortisol excretion in the urine(4 days)
- Reduction of cortisol levels in the urine(4 days)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
4 期
Norfloxacin In The Primary Prophylaxis Of Spontaneous Bacterial PeritonitisHepatorenal SyndromeSpontaneous Bacterial PeritonitisCirrhosisNCT00359853Hospital Clinic of Barcelona70
招募中
不适用
Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in CirrhosisCirrhosisNCT01212250Institute of Liver and Biliary Sciences, India132
已完成
4 期
Pravastatin Efficacy and Safety Trial in Hypercholesterolemic Patients With Chronic Liver DiseaseHypercholesterolemiaNCT00529178Bristol-Myers Squibb232
撤回
3 期
MNK-6105 for Patients With Cirrhosis and High Ammonia Levels Affecting Brain FunctionHepatic EncephalopathyNCT04128462Mallinckrodt
已完成
2 期
Rifamycin in Minimal Hepatic EncephalopathyCirrhosis, LiverHepatic EncephalopathyNCT04082780Hunter Holmes Mcguire Veteran Affairs Medical Center30