Preoperative Whole-Body Hyperthermia in Patients Undergoing Major Abdominal Cancer Surgery: A Randomized Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Immune Status
研究概览
简要总结
The investigators hypothesize that preoperative hyperthermia improves postoperative complications and compare a placebo group with standard thermoregulatory management (normothermia) to a treatment group receiving 2,5 hours of hyperthermia (38.5-39.5 °C core temperature) in a randomized, single blinded, controlled trial.
详细描述
The investigators hypothesize that preoperative hyperthermia improves postoperative complications and compare a placebo group with standard thermoregulatory management (normothermia) to a treatment group receiving 2,5 hours of hyperthermia (38.5-39.5 °C core temperature) in a randomized, single blinded, controlled trial.
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
- Single (Participant)
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
- •Male and female patients, age 18 - 75
- •Open abdominal, curative cancer surgery > 2 h
排除标准
- •Pregnancy
- •Chronic cortisone treatment
- •Ongoing chemotherapy
- •Acute infections, septic surgery
- •Palliative surgery (e.g. debulking only)
结局指标
主要结局
Immune Status
时间窗: 24 hours after surgery
LPS induced TNF-alpha
次要结局
未报告次要终点
研究者
Oliver Kimberger
Assoc.Prof.PD Dr. MSc
Medical University of Vienna