Impact of early oral feeding after endotherapy in acute variceal bleeding on outcomes in patients with chronic liver disease: An open-label randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence of rebleeding within 5 days of onset of AVB (ie cumulative incidence of failure to control bleed and very early rebleeding) in both arms.
研究概览
简要总结
The present randomized controlled trial was designed to evaluate the impact of early initiation of oral nutrition during acute variceal bleedingon outcomes of early rebleeding in patients with chronic liver disease.
Patients will be randomized in a 1:1 ratio to either oral nutrition arm or systemic fasting arm
Group-A: Early oral nutrition arm:
Route of administration: At the time of endotherapy, nasogastric tube will be placed in the intervention arm.
Timing of initiation and duration of intervention: 1 hour after endotherapy. To be continued till 48 hours from endotherapy.
Composition of feed: Polymeric commercial formula of 1600Kcal per day and 60 g proteins per day with energy density of 1 Kcal/ml will be provided. Feed would be given over 16 hours per day with 8 hours of rest at night.
Protocol violation: Any patient with less than 500Kcal per day of feed will be treated as protocol violation.
Group-B: Systemic fasting for 48 hours after endotherapy as per recommendations of EASL. During the period, patients will be given dextrose normal saline for 48 hours at the rate of 75ml/hour. Sips of oral liquids will be allowed.
Post-intervention follow up- After 48 hours of endotherapy, patients in both arms will be given a standard dietary chart catering to 25kCal/kg and 1g/kg protein according to body weight. Patients will be taking non-selective beta blockers for secondary prophylaxis and will undergo repeat endoscopy at 3-week interval for further eradication of varices. The duration of present study is 6 weeks. Patients will be followed at outpatient clinics at 1st week, 3rd week and 6th week as well as telephonically contacted and prespecified outcomes will be enquired from them.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 14.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •cirrhosis decompensated with ascites who presents with acute variceal bleeding and had undergone endotherapy for esophageal/ gastric varices.
排除标准
- •Cirrhosis without ascites 2)ACLF at presentation 3)Cirrhosis with HCC 4)Pregnancy and lactation 5)Refusal to give consent.
- •Infections like spontaneous bacterial peritonitis, pneumonia, cellulitis at presentation 7)Age less than 14 or more than 65 years 8)Patients with non-cirrhotic portal hypertension 9)Patients undergoing rescue therapy like Ella-Dennis stent placement or rTIPS 10) Acute kidney injury (serum creatinine>1.5mg/dl) at presentation 11)Acute variceal bleeding with shock persisting for more than 1 hour (MAP<60 mm Hg) afterendotherapy.
结局指标
主要结局
Incidence of rebleeding within 5 days of onset of AVB (ie cumulative incidence of failure to control bleed and very early rebleeding) in both arms.
时间窗: within 5 days of onset of AVB in both arms.
次要结局
- 1)Incidence of early rebleeding(2)Incidence of post-bleeding infections during episode of AVB)