EUCTR2014-005337-31-BE进行中（未招募）1 期
Crystalloids or colloids for goal-directed fluid therapy with closed-loop assistance in major surgery?
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- CHU Brugmann
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Adult patients (over the age of 18) undergoing elective major abdominal surgery that is expected to take longer than 3 hours and requiring a general anesthesia and a minimally invasive cardiac output monitoring (Vigileo/Flotrac).
- •Patients who provide written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 107
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 53
排除标准
- •Patients under 18 years of age
- •Patients not undergoing surgery, requiring anesthesia, or cardiac output monitoring.
- •Patients with arrhythmia and/or atrial fibrillation
- •Patients who are allergic to HES
- •Patients with renal insufficiency (serum creatinine of >2 mg/ml) or hepatic dysfunction (liver enzymes >1.5)
- •Patients who has coagulation disorders (please define: values higher than 1.5x normal values.
- •Patients without the capacity to give written informed consent or refusal of consent.
- •Patients included in another protocol within a period of 3 months or Participating in another randomised trial.
- •Pregnancy at time of enrolment.
研究者
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