A Retrospective, Open-label, Uncontrolled Cohort Study to Assess the Effectiveness and Safety of Lactulose Retention Enema in the Treatment of Cirrhotic Patients With Grade 3 or 4 (West Haven Criteria) Hepatic Encephalopathy (HE) [The RETRO Study]
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Complete Reversal
研究概览
简要总结
This is a retrospective study in adult patients with cirrhosis and grade 3 or 4 HE (West Haven Criteria) to evaluate the effectiveness and safety of lactulose retention enema in the treatment of deep grade HE (West Haven Criteria). The study will be conducted retrospectively in a multi center of a multispecialty tertiary care hospital in India, in which lactulose retention enema is the mainstay of management of cirrhotic patients with grade 3 or 4 HE (West Haven criteria). Dosing of lactulose retention enema in this study will be done according to the dosing described for rectal administration of lactulose (India): 300ml of lactulose mixed with 700ml of potable water to be used as a retention enema; the enema is to be retained for 30-60 minutes and repeated every 4-6 hours until the patient is able to take oral medication. This treatment regime is also the standard protocol of management of deep grade HE (West Haven criteria) in the study centers. The standard treatment protocol of deep grade HE (West Haven criteria) of the study centers will also ensure that all known contraindications of lactulose will be respected before administration of lactulose retention enema to the study patients. The retrospective hospital records of the patient population of interest within the past 6 months will be identified, and these records will be used to collect data required for analysis.
详细描述
Data to be collected:
Data that would be collected for the study as part of retrospective chart review:
- Patient demographics: age, gender, weight
- Medical history
- Etiology of cirrhosis (alcohol abuse, hepatitis, autoimmune, cryptogenic, other)
- Diagnosis of cirrhosis
- History of previous HE (if yes, the number of episodes in the past)
- Grade of HE (as per the West-Haven criteria) at admission, 24 hrs and 48 hours post treatment with lactulose
- Precipitating factor(s) of HE (Dehydration, GI bleeding, protein overload, constipation, infection, others)
- Dose and duration of lactulose enema
- Treatment given for precipitating factors
- Laboratory data on haemoglobin, platelet, bilirubin, albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), urea, creatinine, sodium, potassium, and blood ammonia
- Complete reversal of deep-grade HE (< Grade 2 as per West-Haven criteria) (yes/no)
- Time to complete reversal of deep-grade HE
- Number of days in hospital
- Adverse drug reaction experienced by the patient
- Complications experienced by the patient
- Other pharmacovigilance relevant information (OPRI)
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 65 years of either gender.
- •Patients admitted to the hospital with liver cirrhosis and grade 3 or grade 4 (West Haven Criteria) HE
- •Patients treated with lactulose retention enema within 48 hours of onset of grade 3 or 4 (West Haven Criteria) HE
排除标准
- •Patients treated with agents other than lactulose retention enema for grade 3 or 4 (West Haven Criteria) HE.
- •Patients who had significant concomitant diseases that could impair or contribute to the impairment of consciousness
- •Patients who had a major neuropsychiatric illness
- •Patients who had a contraindication to lactulose, including Hypersensitivity to the active substance or to any of the ingredients; Galactosaemia; Gastrointestinal obstruction, digestive perforation or risk of digestive perforation
结局指标
主要结局
Complete Reversal
时间窗: 48 hrs
Percentage of patients with complete reversal of deep-grade (Grade 3 and 4 West-Haven Criteria) Hepatic Encephalopathy after administration of lactulose retention enema
次要结局
- Time to Complete Reversal(up to 48 hrs)
- Mortality(within 48 hrs)
- Hepatic Encephalopathy (HE) Grade Shift at 24 and 48 Hours(HE Grade shift at 24 hrs and HE Grade shift at 48 hrs)