Perioperative Management of Deep Inferior Epgastric Perforator (DIEP) Flap for Breast Reconstruction
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Free flap survival rate
研究概览
简要总结
By comparison of two different protocols with diverse fluid/ catecholamine administration limits (fluid restriction vs. catecholamine restriction with target systolic blood pressure > 100 mmHg) the investigators would like to reveal the impact of intraoperative blood pressure management on the survival rate of free deep inferior epigastric artery flaps for breast reconstruction.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Fluid restriction
Crystalloid fluid max. 2.0 ml/kg/h, no administration of colloids, noradrenaline max. 0.15 µg/kg/min
干预措施: Crystalloid Solutions (Drug)
Catecholamine restriction
Noradrenaline max. 0.04 µg/kg/min, fluids max. 8.0 ml/kg/h
干预措施: Catecholamines (Drug)
结局指标
主要结局
Free flap survival rate
时间窗: 5 days postoperatively
Rates of (partial) flap loss in each study arm
次要结局
- Period of hospitalization(up to 14 days)
研究者
Dr. Alexandra Anker
Principal Investigator
University of Regensburg