Efficacy and Safety of Continuous Infusion of Terlipressin vs Bolus Terlipressin in ACLF Patients With Acute Esophageal Variceal Bleed -Pilot Study.
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- HVPG responder at 12-24 hours in both arms
研究概览
简要总结
Acute portal hypertension, as measured by rapid rise in hepatic venous pressure gradient (HVPG) can lead to further dreaded complications, including acute variceal bleeding (AVB)
AVB: 6-week mortality rates of around 15–20% in patients with chronic liver disease without ACLF.The overall prevalence of UGH in cirrhotic patients with AD was 34.4% and 35.7% in patients with ACLF.AVB is a well-recognized precipitant leading to the occurrence and development of ACLF. AVB is a well-recognized precipitant leading to the occurrence and development of ACLF. Medical therapy for esophageal variceal bleeding (EVB) aims to reduce the splanchnic blood flow and portal pressure. The most common vasoactive agents include terlipressin, vasopressin, somatostatin, and octreotide.
Aim and Objective – To assess the safety and efficacy of continuous terlipressin vs. Bolus terlipressin in the management of acute esophageal variceal bleeding in ACLF.
Study population: Adult patients diagnosed with ACLF presenting with upper GI bleeding due to esophageal varices.
Study design: Pilot study
Study period: 1 year
Sample size: 60
Intervention:
Group I- Intravenous terlipressin (administered as a continuous infusion at 4 mg per 24 hours). After 12 hours, if the hepatic venous pressure gradient (HVPG) does not show a reduction of less than 10%, increase the dose to 6 mg per 24 hours.
Group II- Intravenous terlipressin (2 mg initially every 4 hourly for 2 days and then 1 mg every 4 hrs)
Monitoring and assessment: All patients would undergo vital and baseline parameter screening before randomization. Based on randomization they will receive either steroid or plasma exchange followed by steroid
Adverse effects:
Acute Diarrhea, chest pain, Arterial hypertension, Cardiac arrhythmias, Acute abdomen
Stopping rule: chest pain, alteration of ECG, cyanosis, bradycardia, severe allergic rashes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients (age more than equals to 18 years) diagnosed with ACLF presenting with due to esophageal varices bleeding.
排除标准
- •History of coronary heart disease or ventricular arrhythmia,
- •Stroke or transient ischemic attack,
- •Bronchial asthma,
- •Epilepsy,
- •Pregnancy,
- •Rebleeding.
- •Gastric variceal bleed.
结局指标
主要结局
HVPG responder at 12-24 hours in both arms
时间窗: 12-24 hours
次要结局
- 6 weeks mortality in both groups(6 weeks)
- Failure to control hemostasis(5 days)
- Terlipressin-related complications within 5 days i.e. safety of the drug(5 days)
- Number of blood transfusions at 5 days(5 days)
- Rebleed within 42 day.(42 days)
- Incidence of post-bleed AKI within 5 days.(5 days)
研究者
Dr Khushboo Yadav
Institute of Liver and Biliary Sciences