To Study the Hemodynamic Response of Early Addition of Carvedilol to Terlipressin in Acute Variceal Bleed in Child's B and C Cirrhosis- A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Hemodynamic response in both groups
研究概览
简要总结
Management of Acute variceal bleeding includes endoscopic variceal ligation (EVL) along with vasoactive agents. Inspite of successful hemostasis, this is associated with high variceal rebleeding (VRB) in Child B and C cirrhosis and have higher 6-week mortality rates. Pre-emptive TIPS has shown to prevent rebleed and improve survival in child B and C patients but is associated with liver related complications in advanced disease. HVPG guided therapy and treatment response is known to improve rebleeding and associated with improved survival. This is based on achieving hemodynamic response defined as HVPG reduction of ≥20% from baseline or absolute reduction of HVPG </= 12 mmHg for secondary prophylaxis for prevention of rebleeding. Studies have shown the safety of giving terlipressin in patients receiving beta- blockers. We aim to achieve hemodynamic response with addition of carvedilol with vasoactive agent for reduction of portal blood flow to decreases rebleeding episodes and reduce mortality.
详细描述
Aim and Objective To compare the hemodynamic response of early addition of carvedilol with terlipressin in patients with cirrhosis presenting with acute esophageal variceal bleeding.
Primary objective • To study the hemodynamic response (HVPG reduction of ≥20% from baseline or absolute reduction of HVPG </= 12 mmHg) in the groups at 5-days.
Secondary objective
- Rebleeding rate in the two groups at 5-days
- Rebleeding rate at 6-weeks
- Reduction of HVPG <16mm Hg in both groups at 5-days
- Salvage treatment, TIPS in both groups at 5-days and at 6-weeks
- Salvage treatment, SEMS, SB tube placement in-between groups at 5-days and at 6- weeks
- Survival at 6-weeks
- Liver related decompensation in-between groups at 6-weeks
- Adverse events between the groups at 6-weeks
Methodology:
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhosis with Acute Variceal Bleed
- •Child's B and C cirrhosis (CTP ≤ 12)
- •Patients age between 18 to 75 years
排除标准
- •Gastric variceal bleed
- •Bleeding related to coagulopathy
- •Other causes of portal hypertensive bleeding
- •Acute on chronic liver failure
- •Shock(persistence of hypotension)
- •Acute kidney injury (>1.5 mg%)
- •Grade 3 Ascites
- •Hyponatremia (Na < 125 mEq/L)
- •Complete portal vein thrombosis
- •Hepatocellular carcinoma (>3cm lesion)
- •Tumoral portal vein thrombosis
- •Chronic kidney disease
- •Coronary artery disease
- •Valvular heart disease
- •Sick sinus syndrome/ Pacemaker
- •Arrythmia
- •Uncontrolled hypothyroidism and hyperthyroidism
- •Pregnancy
- •Failure to give consent
研究组 & 干预措施
Carvedilol at Day6 + Standard Medical Treatment
Arm B- Carvedilol will be initiated on day 6, at a dose of 3.125mg twice a day (6.25mg/day), along with standard management as per institutional protocol for AVB.
All patients to receive Inj. Terlipressin, 1 mg at 4 hours along with standard management for acute variceal bleed as per institutional protocol
干预措施: Standard Medical Treatment (Other)
Carvedilol at Day2 + Standard Medical Treatment
Arm A- Carvedilol will be initiated on day 2, at a dose of 3.125mg twice a day (6.25mg/day), along with standard management as per institutional protocol for AVB.
All patients to receive Inj. Terlipressin, 1 mg at 4 hours along with standard management for acute variceal bleed as per institutional protocol
干预措施: Carvedilol Day2 (Drug)
Carvedilol at Day2 + Standard Medical Treatment
Arm A- Carvedilol will be initiated on day 2, at a dose of 3.125mg twice a day (6.25mg/day), along with standard management as per institutional protocol for AVB.
All patients to receive Inj. Terlipressin, 1 mg at 4 hours along with standard management for acute variceal bleed as per institutional protocol
干预措施: Standard Medical Treatment (Other)
Carvedilol at Day6 + Standard Medical Treatment
Arm B- Carvedilol will be initiated on day 6, at a dose of 3.125mg twice a day (6.25mg/day), along with standard management as per institutional protocol for AVB.
All patients to receive Inj. Terlipressin, 1 mg at 4 hours along with standard management for acute variceal bleed as per institutional protocol
干预措施: Carvedilol Day6 (Drug)
结局指标
主要结局
Hemodynamic response in both groups
时间窗: Day 5
Hemodynamic response (HVPG reduction of ≥20% from baseline or absolute reduction of HVPG \</= 12 mmHg) in the groups at 5-days.
次要结局
- Rebleeding within 6-week in both groups(6-weeks)
- Death in both groups(6-weeks)
- Adverse Effects in both groups(6 weeks)
- Decompensation events (ascites) at 6-weeks in both groups(6 weeks)
- Decompensation events (Hepatic Encephalopathy) at 6-weeks in both groups(6 weeks)