Clinical Trial on the Effects of Long Term Administration of 20% Albumin in the Cardiovascular and Renal Function, And Hepatic Hemodynamics in Advanced Patients With Cirrhosis and Ascites.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 6
- 主要终点
- To asses change from Baseline plasma renin concentration at Week 14
研究概览
简要总结
Effects of long term albumin administration on the cardiocirculatory and renal function and hepatic hemodynamics in patients with advanced cirrhosis and ascites.
详细描述
Pharmacodynamic study of pathophysiological nature to assess the effects of prolonged administration of human albumin in the cardiocirculatory and renal function and hepatic hemodynamics in patients with advanced cirrhosis and ascites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above 18 years and less than 80 years.
- •Diagnosis of liver cirrhosis by biopsy or by clinical, laboratory, or ultrasound.
- •Daily requirement of diuretics at least 200mg of spironolactone or 100mg of spironolactone and 40 mg of furosemide
- •Renal dysfunction defined by a plasma concentration of serum creatinine ≥ 1.2 mg / dl, blood urea nitrogen ≥ 25 mg / dl or a serum sodium concentration ≤ 130 mEq / L.
排除标准
- •Refractory Ascites (paracentesis requirements over 1 month.
- •Neoplastic disease including liver cancer if it exceeds the Milan criteria (one nodule> 5 cm or three nodules> 3 cm).
- •History of transjugular intrahepatic portosystemic shunt (TIPS) or surgical shunt
- •Gastrointestinal bleeding or bacterial infection documented in the past 15 days.
- •Heart failure or structural heart disease.
- •Organic renal insufficiency(proteinuria, hematuria and / or ultrasound data nephropathy).
- •Moderate or severe lung chronic disease.
- •Transplant.
- •Infection with human immunodeficiency virus.
- •Active addiction to drugs.
- •Mental state that prevents the patient understand the nature, extent and consequences of the study, except for hepatic encephalopathy.
- •Pregnancy.
研究组 & 干预措施
Albumin
The subjects will be receiving albumin 20% infusions
干预措施: Albumin (Drug)
结局指标
主要结局
To asses change from Baseline plasma renin concentration at Week 14
时间窗: 14 weeks
Plasma renin activity will be measured at Baseline and Week 14
To asses change from Baseline plasma renin concentration at Week 20
时间窗: 20 weeks
Plasma renin activity will be measured at Baseline and Week 20
To asses change from Baseline plasma concentration of noradrenaline at week 14
时间窗: 14 weeks
Plasma noradrenaline concentration will be measured at Baseline and Week 14
To asses change from Baseline plasma concentration of noradrenaline at Week 20
时间窗: 20 weeks
Plasma noradrenaline concentration will be measured at Baseline and Week 20
To assess change from Baseline glomerular filtration rate at Week 14
时间窗: 14 weeks
Glomerular filtration rate will be measured at Baseline and Week 14
To assess change from Baseline glomerular filtration rate at Week 20
时间窗: 20 weeks
Glomerular filtration rate will be measured at Baseline and Week 20
To assess change from Baseline cardiac output at Week 14
时间窗: 14 weeks
Cardiac output will be measured at Baseline and Week 14
To assess change from Baseline cardiopulmonary pressures at Week 14
时间窗: 14 weeks
Cardiopulmonary pressures will be measured at Baseline and Week 14
To assess change from Baseline free hepatic pressure at Week 14
时间窗: 14 weeks
Free hepatic pressure will be measured at Baseline and Week 14
To assess change from Baseline wedged hepatic pressure at Week 14
时间窗: 14 weeks
Wedged hepatic pressure will be measured at Baseline and Week 14
To assess change from Baseline echocardiography at Week 14
时间窗: 14 weeks
Echocardiography will be measured at Baseline and Week 14
次要结局
未报告次要终点