Is Continuous Lactulose Therapy Necessary for Patients With Hepatic Encephalopathy? A Prospective Study of Controlled Lactulose Withdrawal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Psychometric function and relapse into clinical HE
研究概览
简要总结
After resolution of the initial episode of hepatic encephalopathy (HE), lactulose is routinely continued indefinitely as maintenance therapy. Although widely used for this indication, lactulose has never been shown in randomized, controlled trials to be effective for preventing exacerbations of HE. Indeed, lactulose was found to be ineffective at preventing HE when administered prophylactically to patients undergoing portosystemic shunt insertion. While some patients may be lactulose dependent following an initial episode of HE, it is likely that most could have their lactulose discontinued with no adverse consequences.
This goal is worth pursuing because lactulose is not innocuous. It has an unpleasant taste, and it routinely produces gastrointestinal symptoms, including bloating, gas and diarrhea. In high doses it can cause incontinence, dehydration and electrolyte derangements. Patients universally dislike taking lactulose and often are noncompliant with treatment. A recent trial showed that patients on lactulose had a substantial risk of hospital admissions due to lactulose-related complications and treatment non-compliance.
详细描述
In this pilot study we propose to perform controlled lactulose withdrawal in selected patients with HE whose initial presentation follows a clearly defined, reversible precipitating event or those with stable, chronic HE. We hypothesize that a majority of these patients can be withdrawn from daily lactulose therapy without deterioration of cognitive function, and that lactulose withdrawal will improve symptoms and quality of life for these individuals. We propose to carry out a comprehensive battery of clinical, laboratory, microbiological and psychometric evaluations before and after lactulose withdrawal. We will closely follow changes in cognitive function and re-institute lactulose therapy at the first sign of clinical deterioration. Through multivariate analysis we propose to develop a model to discriminate between treatment dependent and treatment independent patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of hepatic cirrhosis based on biopsy, clinical and/or radiological findings.
- •Stable HE (chronic): On daily lactulose for more than 6 months without hospitalization for HE within 3 months of enrollment.
- •Treated with lactulose on a daily basis, with restoration of mental status to baseline.
- •Lives with an adult individual who is willing to serve as a full-time caregiver.
- •Able and willing to give informed consent.
排除标准
- •Use of antibiotics, including rifaximin.
- •Patient without an adult caregiver.
- •Pre-existing focal neurological deficits, seizures or other indication of structural neurological disorder.
- •Actively abusing illicit drugs or alcohol.
研究组 & 干预措施
Lactulose withdrawal
Patients who were started on lactulose as a result of a precipitated HE episode underwent analysis while they were on lactulose; after this they underwent a controlled lactulose withdrawal with 3 visits post-withdrawal at 2 days, 14 days and 30 days after lactulose withdrawal
干预措施: lactulose (Drug)
结局指标
主要结局
Psychometric function and relapse into clinical HE
时间窗: 30 days
次要结局
- MR Spectroscopy(30 days)
- Pro-inflammatory cytokines(30 days)
- Stool bacterial DNA analysis(30 days)
- Urine and blood for metabolomics(30 days)
- Quality of life(30 days)
研究者
Jasmohan Bajaj
Associate Professor of Medicine
Hunter Holmes Mcguire Veteran Affairs Medical Center