Effects of Tolvaptan on Cognitive Function, Brain Metabolism and Quality of Life in Hyponatremic Cirrhotics With Hepatic Encephalopathy: A Prospective Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Cognitive performance
研究概览
简要总结
Hypothesis: Tolvaptan will improve cognitive function, brain edema and health-related quality of life in cirrhotic patients with hyponatremia
详细描述
Baseline assessment will include a
- battery of eight cognitive tests
- Health related quality of life
- MRI head evaluating MR spectroscopy and diffusion tensor imaging
Patients will then be given tolvaptan 15-30mg qd for 14 days after which the tests will be repeated. During the first 3 days of tolvaptan administration, patients will be admitted and serum sodium will be drawn every 8 hours. 24 hr urine collection will also be performed.
Between the initiation and end of tolvaptan, patients will be seen at least every 3-5 days in between.
Participation will be terminated in case patients get transplanted or develop overt HE in between.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhosis diagnosed by liver biopsy or radiological evidence of nodular cirrhotic liver or varices on endoscopy or laboratory features (platelet count <150,000 with an AST/ALT ratio >1).
- •History of HE controlled on lactulose and/or rifaximin
- •Last HE episode >2 months prior to enrollment and <2 episodes within 6 months
- •Mini-mental status exam score ≥25
- •Serum sodium <130mg/dl within the last 14 days and the day of enrollment
- •Availability of a caregiver
- •Able to undergo MR of the head
排除标准
- •Uncontrolled HE manifested by MMSE <25
- •Alcohol abuse within 3 months
- •Illicit drug use within 3 months
- •Psychoactive drug use other than regularly scheduled anti-depressants or methadone.
- •Contraindication to MR examination (see attached MRI Safety Form)
- •Placement of a transjugular intra-hepatic portosystemic shunt (TIPS)
- •Creatinine Clearance less than 10 ml/min or undergoing hemodialysis
- •HIV infection
- •Use of azole medications
- •Pregnancy
- •Current use of tolvaptan, hypertonic saline or other medical therapies for hyponatremia
研究组 & 干预措施
Tolvaptan
Open label study of tolvaptan. First 3 days as an inpatient then outpatient for the remainder of the study
干预措施: Tolvaptan (Drug)
结局指标
主要结局
Cognitive performance
时间窗: 14 days
次要结局
- Brain Diffusion Tensor Imaging(14 days)
- Health-related Quality of Life(14 days)
- Brain MR Spectroscopy(14 days)
研究者
Jasmohan Bajaj
Associate Professor of Medicine
Hunter Holmes Mcguire Veteran Affairs Medical Center