Terlipressin Administration in Patients Undergoing Major Liver Resection: a Prospective Randomized Blinded Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Number of patients with incident of a composite end point
研究概览
简要总结
This study investigates if the administration of terlipressin reduces complications after major liver surgery.
详细描述
Background
Surgery offers the only potential cure in many patients with primary or metastatic liver cancer. Extending the limits and improving safety of liver resection would allow more patients to benefit from surgery and to increase their survival. The prerequisite for successful and safe liver surgery is the optimal regeneration of the remaining hepatic tissue in order to fulfill the metabolic demands of the patient. Liver regeneration depends on a correct portal pressure and portal blood flow. In the preliminary results the investigators show an elevation of portal pressure post partial hepatectomy in mice. Pharmacologic reduction of such elevated portal pressure using terlipressin, a vasopressin agonist, was associated with improved liver regeneration.
Objective
Surgery offers the only potential cure in many patients with primary or metastatic liver cancer. Extending the limits and improving safety of liver resection would allow more patients to benefit from surgery and to increase their survival. Liver regeneration depends on a correct portal pressure and portal blood flow. Pharmacologic reduction of elevated portal pressure using terlipressin, a vasopressin agonist, is potentially associated with improved liver regeneration. Aim: To perform a prospective randomized trial comparing terlipressin versus placebo in patients undergoing major hepatic resection.
Methods
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
- Double (Participant, Investigator)
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
- •Patients undergoing resection of 3 or more liver segments
- •Minimum age of 18
- •Any gender
- •Written informed consent
- •Exclusion Criteria
- •Preoperative renal failure (GFR < 50ml/min)
- •Severe liver dysfunction (Child-Turcotte-Pugh grade C)
- •Hyponatremia (<132mmol/l)
- •Severe aortic regurgitation, severe mitral regurgitation, heart failure
- •Symptomatic coronary heart disease
- •Bradycardic arrhythmia (heart rate < 60/min)
- •Peripheral artery occlusive disease (clinical stadium II-IV)
- •Dilatative arteriopathy, history of subarachnoidal bleeding
- •Decompensated arterial hypertension (Blood pressure >160/100mmHg despite intensive treatment)
- •Present or suspected acute mesenteric ischemia
- •Septic shock
- •Pregnancy
排除标准
- 未提供
研究组 & 干预措施
Terlipressin
Terlipressin given as intravenous injections of 1mg iv in 100ml of NaCl every 6 hours (total duration of drug administration 120 hours, cumulative dose is 20mg).
干预措施: Terlipressin (Drug)
NaCl
Placebo (Saline 100 ml) administered every 6 hours (total duration of drug administration 120 hours).
干预措施: Placebo (Drug)
结局指标
主要结局
Number of patients with incident of a composite end point
时间窗: one month
次要结局
- Number of patients with pleural effusion(one month)
- Number of patients with surgical site infection(one month)
- Number of patients with sepsis(one month)
- Number of patients with pneumonia(one month)
- Number of patients with intraabdominal hematoma(one month)
- Number of patients with acute renal failure(one month)
- Number of patients with blood transfusion(one month)