Description of Lactulose Administration by Balloon Rectal Tube in Severe Hepatic Encephalopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Describe ammonia during lactulose administration by balloon rectal tube
研究概览
简要总结
Acute liver failure in cirrhotic patients is associated with a one-month mortality of 48%. Encephalopathy, largely related to hyperammonemia, is a frequent complication of liver failure and is a poor prognostic marker. Lactulose decreases ammonia by acidification of the colon, replacement of urease-producing bacteria and creation of a laxative effect. Thus, the administration of lactulose in patients with severe hepatic encephalopathy reduces mortality by more than 40%.
In intensive care patients, lactulose is often administered rectally. The use of simple rectal tubes is associated with frequent leakage of lactulose as well as faecal discharge and therefore risks of infection and skin lesions. Balloon rectal tubes with a drug delivery valve have recently been developed and used in this indication. The aim of this study is therefore to describe the use of these balloon rectal tubes to administer Lactulose in severe hepatic encephalopathy.
This suggests that ammonia reduction in these patients may prolong survival time.
No studies have described the administration of Lactulose via the rectal route with a balloon tube. The descriptive methodology is therefore appropriate. This is a preliminary study allowing data collection to establish the methodology for a subsequent clinical trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •> 18 years
- •Patients treated with Lactulose with balloon rectal probe
排除标准
- •Patient(s) objecting to the use of their data for research purposes
- •Rectal probe contraindication: damage to the rectal mucosa, rectal surgery, severe haemorrhoids, rectal stenosis, rectal tumour,
- •Lactulose contraindication (person unable to absorb galactose)
- •Patients deprived of liberty, under guardianship or curators
- •Pregnant women
- •Patient not affiliated to a social security scheme
结局指标
主要结局
Describe ammonia during lactulose administration by balloon rectal tube
时间窗: 48 hours
Variation of ammonia before treatment and after 48h of treatment
次要结局
- Describe the neurological course following administration of lactulose via a balloon rectal tube(at 7 days)
- Describe ammonia levels after lactulose administration via balloon rectal tube.(at 7 days)
- Describe the skin tolerance of patients during hospitalization.(at 7 days)
- Describe complications related to the balloon rectal tube(at 7 days)
- Describe complications related to rectal lactulose administration(at 7 days)
- Patient outcomes(at 28 days)
- Caregiver satisfaction(at 7 days)
- Describe balloon rectal probe retention(at 7 days)