Intestinal decontamination with rifaximin. Effects on the inflammatory and circulatory state in patients with cirrhosis and ascites- A randomised controlled clinical study

Flemming Bendtsen0 个研究点开始时间: 2012年8月16日最近更新: 2016年3月14日

适应症

试验速览

暂无简介。

•-Patients with decompensated liver cirrhosis and clinical signs of ascites, verified by ultrasonography or CT scan within the last three months.
•-Age between 18 and 80 years.
•-Portal hypertension and a hepatic venous pressure gradient (HVPG) of 10 mmHg or more.
•-Women of child-bearing age should use safe anti conception, defined as either hormonal anti conception or intrauterine device.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 17

•-Child-Pugh Score above 13
•-Clinical signs of infection evaluated by blood biochemistry, urine culture and if applicable ascites puncture, and through clinical assessment by the investigator.
•-Received antibiotic treatment within 14 days prior to inclusion
•-Presence of hepatocellular carcinoma.
•-Ongoing invasive cancer or invasive cancer within the last five years,
•-Overt hepatic encephalopathy (HE above grade 1),
•-Serum creatinine > 200 mmol/l,
•-Transfusion requiring bleeding within one week prior to inclusion,
•- S-hemoglobin levels of < 5,5 mmol/L
•-Severe cardiac, pulmonary or kidney diseases or Type 1 diabetes mellitus,
•-Continuous alcohol abuse with symptoms of abstinence
•-Expected survival less than 3 months,
•- Denied consent

发起方

Flemming Bendtsen