HELP Trial: Efficacy of L-Ornithine L-Aspartate and Polyethylene Glycol in Cirrhotic Patients With Overt Hepatic Encephalopathy
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 360
- 试验地点
- 6
- 主要终点
- Patient recovery among all groups through a change in mental state.
研究概览
简要总结
The goal of this clinical trial is to compare the efficacy of L-ornithine L-aspartate and Polyethylene Glycol in Cirrhotic Patients with Overt Hepatic Encephalopathy.
Participants will be asked to fill out a few questions on proforma that will obtain demographic information as well as information relating to the patient's health. Treatments that they will receive after inclusion in the study, will be the standard treatment (Lactulose) along with additional medication as part of our research (LOLA or Polyethylene glycol).
详细描述
This is a randomized control trial with the following objectives
- what is the efficacy of add-on LOLA therapy in patients of overt HE (Grade II and above) against the standard-of-care arm
- what is the efficacy of adding on polyethylene glycol (PEG) in overt HE (Grade II and above) against the standard-of-care arm
Randomization will be done using card randomization. three different color-coded cards will be kept. Any card will be randomly picked for the patient fulfilling inclusion criteria and will be treated according to the allocated treatment arm mentioned on the card
Patients will be diagnosed on the basis of Modified West Haven Criteria. For diagnosis and prognosis, the following tools will be used:
- Modified West Haven criteria and Glasgow coma scale will be used to assess the mental state.
- CLIF-C ADs and CLIF SOFA score will be used as a prognostic score for predicting mortality in hospitalized patients.
- Overt HE patients will be graded using the Hepatic encephalopathy grading instrument (HEGI).
- Child-Pugh classification and MELD scoring will be used to assess the severity of chronic liver disease and cirrhosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
participants' attendants will also be masked and will give consent for the study in case the participant is admitted to the Intensive care unit and is not mentally stable to give consent.
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
- •Admitted cirrhotic patients above 18 years of age,
- •diagnosed on clinical/ultrasound findings with HE (grade 2 or above) with or without precipitating factors.
排除标准
- •Patients with hepatocellular carcinoma
- •severe septicemia,
- •active upper gastrointestinal bleeding and in a state of shock
- •presence of underlying chronic renal failure (serum creatinine >1.5 mg/dl)
- •presence of hepatorenal syndrome
- •neurodegenerative disease
- •patients with a head injury and drug intoxication
- •acute superimposed liver injury
- •advanced cardiac or pulmonary derangements
- •end-stage renal disease
- •pregnant or breastfeeding mothers
- •patients who are on sedatives, antidepressants, or benzodiazepines
研究组 & 干预措施
Lactulose AND LOLA
Lactulose which is the standard of care treatment will be administered with the experimental drug L-ornithine L-aspartate (LOLA).
干预措施: Lactulose oral solution (Drug)
Lactulose AND LOLA
Lactulose which is the standard of care treatment will be administered with the experimental drug L-ornithine L-aspartate (LOLA).
干预措施: L-ornithine L-aspartate (Drug)
Lactulose and PEG
Lactulose which is the standard of care treatment will be administered with the experimental drug polyethylene glycol (PEG).
干预措施: Polyethylene Glycols (Drug)
Lactulose and PEG
Lactulose which is the standard of care treatment will be administered with the experimental drug polyethylene glycol (PEG).
干预措施: Lactulose oral solution (Drug)
Lactulose
This group will receive Lactulose only which is the standard of care treatment.
干预措施: Lactulose oral solution (Drug)
结局指标
主要结局
Patient recovery among all groups through a change in mental state.
时间窗: A change will be assessed at 144 hours post enrollment.
A change of at least one grade in the mental state based on the modified West Haven criteria and hepatic encephalopathy grading scale. A decrease in the grade will be a better outcome.
次要结局
- A change in Quality of Life will be assessed through SF-36(Quality of life will be assessed at 84th day post enrollment.)
- A change in mortality rate(it will be inquired at 84th day post enrollment.)
研究者
ZA
Associate professor
Jinnah Postgraduate Medical Centre