Randomized Double Blind Dummy Controlled Trial Of 24 Versus 72 Hours Of Terlipressin As An Adjuvant Therapy In Acute Variceal Bleed
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Variceal Re-bleed
研究概览
简要总结
The purpose of this study is to determine whether 24 hours of Terlipressin is as effective as 72 hours of Terlipressin in preventing re-bleed once esophageal variceal bleed has been controlled with endoscopic therapy (variceal band ligation or sclerotherapy) in low to moderate risk variceal bleed patients and hence can save cost and may decrease length of hospital stay especially in the I.C.U or high dependency units.
详细描述
The esophageal variceal bleeding is usually controlled with endoscopic treatment of variceal band ligation or sclerotherapy along with vasoactive drugs like Terlipressin or Octreotide. The risk of re-bleeding is highest during the initial 5 days from first presentation. Terlipressin is usually given for 3 days (72 hours). In this study we are trying to prove that among low to moderate risk patients, a short course of 1 day (24 hours) of Terlipressin is as effective as 3 days (72 hours) in preventing re-bleed once bleeding has been controlled with endoscopic therapy. This intervention will save 2 days cost incurred on the Terlipressin and may also help in decreasing the length of hospital stay in future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute esophageal variceal bleed
- •Liver cirrhosis
- •Child's score </= 11
排除标准
- •Patient on Mechanical ventilator and or ionotropic support
- •Active angina, Recent Myocardial infarction or dynamic EKG changes
- •Failure to control variceal bleed on initial endoscopy
- •Gastric variceal bleed
- •Spontaneous bacterial peritonitis at presentation
- •Hepatocellular carcinoma or other liver metastatic malignancy
- •Portal vein thrombosis
研究组 & 干预措施
1
72 hours of Terlipressin
干预措施: Terlipressin (Drug)
2
24 hours of Terlipressin & then next 48 hours of Dummy of Terlipressin
干预措施: Terlipressin & then Dummy (Drug)
结局指标
主要结局
Variceal Re-bleed
时间窗: 120 hours (5 Days)
次要结局
- All cause 30 days mortality(30 days)
- 30 days rebleed(30 days from index bleed)
- Safety of Terlipressin(In Hospital safety)