NCT01559519已完成4 期
Effect of Albumine Infusion in the Prevention of Hepatic Encephalopathy After Transjugular Intrahepatic Portosystemic Shunt
University of Roma La Sapienza0 个研究点目标入组 20 人开始时间: 2012年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- one or more episodes of hepatic encephalopathy (> grade 2 according to West Heven criteria)after TIPS placement
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of albumin infusion to prevent post tips hepatic encephalopathy'
详细描述
The outcome is the prevention of post tips hepatic encephalopathy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Cirrhotic patients
- •TIPS placement
- •Absence of Hepatic Encephalopathy at the enrolement
- •Age > 18 years
- •No pregnancy
排除标准
- •Non-cirrhotic portal hypertension
- •Previous liver transplantation
- •Impossibility to attend the scheduled follow-up including the weekly visit as outpatients during the first month after TIPS (see the description of follow-up below)
- •Sings of overt hepatic encephalopathy as well as a history of persistent HE at entry. The latter as a contraindication for TIPS placement
研究组 & 干预措施
albumin
Active Comparator
cirrhotic patients who underwent tips placement
干预措施: Albumin (Drug)
结局指标
主要结局
one or more episodes of hepatic encephalopathy (> grade 2 according to West Heven criteria)after TIPS placement
时间窗: one month post tips
evaluate the efficacy of albumin infusion to prevent the occurrence of hepatic encephalopathy (\> grade 2 according to West Heven criteria)one months after tips placement
次要结局
- arterial blood pressure >120/80 mmHg and natremia >130 mg/dl in cirrhotic patients one month after TIPS placement(one month after tips placement)
研究者
Prof oliviero Riggio
Professor
University of Roma La Sapienza
相似试验
终止
4 期
The INFECIR-2 Albumin Prevention StudyPneumoniaAdvanced Chronic Liver DiseaseUrinary InfectionOther Bacterial DiseasesCholangitisNCT02034279EASL - CLIF Consortium136
进行中（未招募）
1 期
Albumin administration in the prevention of hepatorenal syndrome and death in patients with cirrhosis, bacterial infections other than spontaneous bacterial peritonitis and high risk of hospital mortality.EUCTR2013-002416-27-BEFundacio Clinic per a la recerca biomedica512
进行中（未招募）
1 期
Albumin administration in the prevention of hepatorenal syndrome and death in patients with cirrhosis, bacterial infections other than spontaneous bacterial peritonitis and high risk of hospital mortality.Male and female cirrhotic patients with advanced cirrhosis (serum creatinine = 1.2 mg/dl, serum sodium = 130 mEq/l and/or serum bilirubin =4 mg/dl), and diagnosis of urinary infection, pneumonia, spontaneous or secondary bacteremia, skin/soft tissue infection, acute cholangitis or suspected bacterial infection at hospital admission or during hospitalization.MedDRA version: 18.1Level: LLTClassification code 10008954Term: Chronic liver disease and cirrhosisSystem Organ Class: 10019805 - Hepatobiliary disordersMedDRA version: 18.1Level: LLTClassification code 10024667Term: Liver cirrhosisSystem Organ Class: 10019805 - Hepatobiliary disordersMedDRA version: 18.1Level: PTClassification code 10019641Term: Hepatic cirrhosisSystem Organ Class: 10019805 - Hepatobiliary disordersMedDRA version: 18.1Level: LLTClassification code 10064704Term: Decompensated cirrhosisSystem Organ Class: 10019805 - Hepatobiliary disordersMedDRA version: 18.1Level: LLTClassification code 10009213Term: Cirrhosis of liverSystem Organ Class: 10019805 - Hepatobiliary disordersMedDRA version: 18.1Level: LLTClassification code 10009211Term: Cirrhosis liverSystem Organ Class: 10019805 - Hepatobiliary disordersEUCTR2013-002416-27-DEFundacio Clinic per a la Recerca Biomedica512
进行中（未招募）
不适用
Albumin administration in the prevention of hepatorenal syndrome and death in patients with cirrhosis, bacterial infections other than spontaneous bacterial peritonitis and high risk of hospital mortality.EUCTR2013-002416-27-NOFundacio Clinic per a la recerca biomedica512
进行中（未招募）
不适用
Albumin administration in the prevention of hepatorenal syndrome and death in patients with cirrhosis, bacterial infections other than spontaneous bacterial peritonitis and high risk of hospital mortality.Patients with advanced cirrhosis (serum creatinine ? 1.2 mg/dl, serum sodium ? 130 mEq/l and/or serum bilirubin ?4 mg/dl), signs of systemic inflammation and urinary infection, pneumonia, skin/soft tissue infection, acute cholangitis or suspected bacterial infection will be includedMedDRA version: 16.0Level: LLTClassification code 10024667Term: Liver cirrhosisSystem Organ Class: 10019805 - Hepatobiliary disordersMedDRA version: 16.0Level: LLTClassification code 10008954Term: Chronic liver disease and cirrhosisSystem Organ Class: 10019805 - Hepatobiliary disordersMedDRA version: 16.0Level: PTClassification code 10019641Term: Hepatic cirrhosisSystem Organ Class: 10019805 - Hepatobiliary disordersMedDRA version: 16.0Level: LLTClassification code 10064704Term: Decompensated cirrhosisSystem Organ Class: 10019805 - Hepatobiliary disordersMedDRA version: 16.0Level: LLTClassification code 10009213Term: Cirrhosis of liverSystem Organ Class: 10019805 - Hepatobiliary disordersMedDRA version: 16.0Level: LLTClassification code 10009211Term: Cirrhosis liverSystem Organ Class: 10019805 - Hepatobiliary disordersEUCTR2013-002416-27-ESFundacio Clinic per a la recerca biomedica512