IVC CLAMP: Infrahepatic Inferior Vena Cava Clamping During Hepatectomy - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- Intraoperative blood loss
研究概览
简要总结
Intraoperative blood loss is a major concern during hepatic resection, as it has been shown to adversely affect patients' perioperative outcome. Reduction of central venous pressure during parenchymal transection has been shown to effectively lower liver hemorrhage. While CVP reduction is mainly achieved via fluid restriction and diuretics, dehydration may impair organ function. Moreover, it may lead to hemodynamic instability, particularly in case of severe bleeding. For this reason the technique of infrahepatic inferior vena cava clamping has been suggested which is able to lower CVP without the need for fluid restriction.
In the present study the two strategies to reduce CVP and by this intraoperative bleeding, namely fluid restriction and inferior vena cava clamping are compared with intraoperative blood loss as primary endpoint.
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, Outcomes Assessor)
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
- •Aged 18 years
- •Scheduled for elective hepatic resection due to any reason
- •American Society of Anesthesiologists (ASA) score I to III
- •Written informed consent
排除标准
- •Medical conditions exposing patient at increased risk for not tolerating liver resection:
- •Cirrhosis (Child-Pugh B and C)
- •(Hereditary) coagulopathy
- •Medical conditions exposing patient at increased risk for not tolerating this trial's study interventions:
- •Severe heart disease (e.g. severe CAD requiring intervention, NYHA IV)
- •Pulmonary hypertension
- •Renal insufficiency (serum creatinin >2mg/dl or >177µmol/l; conversion factor 88.4 or requiring dialysis)
- •Severe hypernatremia (serum sodium >155mmol/l)
- •Severe hyperchloremia
- •For female subjects: pregnancy and lactation
- •Impaired mental state or language problems
- •Participation in other clinical trials or observation period of competing trials interfering with the endpoints of this trial
- •Former participation in the clinical trial
- •Expected lack of compliance
结局指标
主要结局
Intraoperative blood loss
时间窗: End of operation
次要结局
未报告次要终点