NCT04771104已完成不适用
The Effect of Induced Hyperammonaemia on Sleep and Melanopsin-mediated Pupillary Light Response in Patients With Liver Cirrhosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Difference in the late post-illumination pupillary response after intervention compared to placebo
研究概览
简要总结
Sleep disturbances are common among patients with liver cirrhosis, but the reasons are not well understood. In this project the investigators evaluated whether an increase in blood ammonia in patients with cirrhosis had an impact on sleep quality and the function of retinal ganglion cells measured by pupillary response to blue light.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a clinical diagnosis of Child Pugh Class A or B cirrhosis
- •Written informed consent
- •>20 and <80 years of age
排除标准
- •Misuse of alcohol in the preceding 6 months,
- •Episodes of hepatic decompensation leading to in-patient admissions during the previous month
- •History or clinical signs of overt HE or severe sleep-wake disturbances
- •On anti-HE treatment (lactulose, rifaximin, Hepa-Merz, Generaid, Bramino)
- •History of significant head injury
- •Neurological/psychiatric comorbidity needing medical treatment
- •Taking neuroactive medication/medication known to affect sleep
- •Travel across more than two time zones in the preceding 3 months
- •Shift work in the preceding 5 years
- •Contraindications for arterial puncture (negative collateral circulation test, wrist infection or vascular abnormalities).
结局指标
主要结局
Difference in the late post-illumination pupillary response after intervention compared to placebo
时间窗: 12 days
次要结局
未报告次要终点
研究者
Peter Nissen Bjerring
Consultant hepatologist, associate professor
Rigshospitalet, Denmark
研究点 (2)
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