NCT01157845已完成3 期
Use of the BreathID Methacetin Breath Test to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Patients Awaiting Liver Transplantation
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 4
- 主要终点
- Mortality From Liver Failure
研究概览
简要总结
The methacetin breath test (MBT) is a non-invasive liver function test which measures the ability of the liver to metabolize a tracer dose of a compound to carbon dioxide, which is exhaled. The study hypothesis is that measurement of the MBT will allow earlier detection of a decline in liver function in patients with cirrhosis who are awaiting liver transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being considered for placement or already on the liver transplantation waiting list
- •Cirrhosis caused by any cause of chronic liver disease.
- •Age > 18 years
排除标准
- •Known or suspected hepatocellular carcinoma
- •Prior TIPS placement
- •Severe congestive heart failure
- •Severe pulmonary hypertension
- •Uncontrolled diabetes mellitus (HBA1C >9.5%)
- •Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication.
- •Previous surgical bypass surgery for morbid obesity (BMI >45)
- •Extensive small bowel resection
- •Patients currently receiving total parenteral nutrition if they have contraindications to oral drugs
- •Women who are pregnant
- •Patients who are allergic to acetaminophen/ paracetamol or any other related medications
- •Patients with an acute current exacerbation of chronic obstructive pulmonary disease or bronchial asthma.
- •Patients that are taking hepatotoxin drugs
- •Patient, based on the opinion of the investigator, should not be enrolled into this study
- •Patient is unable or unwilling to sign informed consent.
- •Patients that are participating in other clinical trials evaluating experimental treatments or procedures
研究组 & 干预措施
Laboratory assay
Experimental
干预措施: BreathID (Methacetin breath test) (Device)
结局指标
主要结局
Mortality From Liver Failure
时间窗: 1 year
Patient dies of liver-related causes within 1 year of study entry
次要结局
- Liver Transplantation(1 year)
研究者
研究点 (4)
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