Diagnosis of Covert/Minimal Hepatic Encephalopathy by Means of Continuous Reaction Time Measurement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Change in Continuous Reaction Time Method versus Portosystemic Encephalopathy Test
研究概览
简要总结
The investigators wish to investigate how the Continuous Reaction Time (CRT) method can be used in the diagnosis and monitoring of covert hepatic encephalopathy (cHE)in patients with cirrhosis of the liver. The hypothesis is that the CRT method (duration 10-2 minutes) can serve as a tool in the diagnosis and monitoring of cHE and is an alternative to using the Portosystemic Encephalopathy Test (PSE)(duration 20-25 minutes).
详细描述
Objective: The aim of this project is to investigate whether continuous reaction time measurements (CRT) are suitable as a screening and monitoring tool for covert hepatic encephalopathy (c/mHE).
Method:
Sub-protocol 1: As a part of this PhD protocol 100 healthy individuals and 50 with chronic disease (not liver cirrhosis) will be tested using the CRT and PSE tests. This is to determine the normal range for the PSE test in the Danish population.
Sub-protocol 2: A total of 120 (aprox. 145 to adjust for drop outs) patients with liver cirrhosis from two Danish hospitals will be examined with both CRT and with the test that is the closest we get to a gold standard, namely portosystemic encephalopathy test (PSE). We wish to examine if the CRT test agrees with the PSE test, which may be to time consuming to perform in everyday clinical practice, and with quality of life scores (SF-36 and Sickness Impact Profile). The relationship between the CRT and PSE test and various blood tests and the Charlston co-morbidity score will also be examined.
Sub-protocol 3: Forty-four of the 120 included patients will, regardless of CRT test result, be randomized to treatment with lactulose, rifaximin and branched chain amino acids (BCAA) or placebo lactulose, rifaximin and BCAA. This is to evaluate whether the CRT method is able to detect a response to treatment, and see if changes in psychometric tests (PSE and CRT) are in accordance with quality of life scores and predicts subsequent development of overt hepatic encephalopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For healthy volunteers:
- •Age> 18 years
- •Written informed consent
- •Speak and understand Danish
- •For patients:
- •Age > 18 years
- •Liver cirrhosis confirmed by biopsy or appropriate clinic and biochemistry, and imaging.
- •Written informed consent
- •Speak and understand Danish
- •Exclusion Criteria (patients and control persons):
- •Clinical manifest hepatic encephalopathy
- •Consumption of psychoactive substances within 6 days of test
- •Organic brain disease (i.e. prior stroke, dementia)
- •Hypothyroidism
- •Renal failure (creatinine> 150 mg / dL)
- •Hyponatremia (Na <125 mmol / L)
- •Sepsis or bleeding within one week prior to testing.
- •Serious sleep disorders
- •Current treatment with lactulose, rifaximin or BCAA
排除标准
- 未提供
研究组 & 干预措施
Anti cHE treatment arm
Of 150 included patients aprox. 44 regardless of CRT and PSE test outcome will be offered to enter randomisation and 3 months follow up. Half of 44 patients will receive both lactulose, rifaximin and branched chain aminoacids (Bramino) the other half placebo.
干预措施: Lactulose and rifaximin (Drug)
Anti cHE treatment arm
Of 150 included patients aprox. 44 regardless of CRT and PSE test outcome will be offered to enter randomisation and 3 months follow up. Half of 44 patients will receive both lactulose, rifaximin and branched chain aminoacids (Bramino) the other half placebo.
干预措施: Branched Chain amino acids (Dietary Supplement)
Placebo arm
The goal of this intervention is to investigate whether the CRT method can detect an expected treatment response after initiation of the 3 named drugs know to ameliorate HE symptoms including psychometric test results.
干预措施: Placebo (Other)
结局指标
主要结局
Change in Continuous Reaction Time Method versus Portosystemic Encephalopathy Test
时间窗: baseline and 3 months
The investigators are evaluating if the CRT and PSE test are in accordance at inclusion and after 3 months of treatment.
次要结局
- Change in Continuous Reaction Time Method versus Quality of Life (QoL)(baseline and 3 months)
- Correlation between psychometric test results and quality of life af base line(at base line)
- Correlation between CRT test and PSE test at inclusion(at baseline)
研究者
Mette Munk Lauridsen
MD, Phd student
Esbjerg Hospital - University Hospital of Southern Denmark