EUCTR2016-002162-30-NL进行中（未招募）1 期
Prospective, randomized, controlled, double-blind, multicentre, multinational study on the safety and efficacy of 6% Hydroxyethyl starch (HES) solution versus an electrolyte solution in patients undergoing elective abdominal surgery - PHOENICS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,280
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
- •Male or female adult patients > 40 and = 85 years of age
- •Women of childbearing potential must test negative on standard pregnancy test (urine or serum)
- •Patients undergoing elective abdominal surgery with an expected blood loss of = 500 ml
- •ASA Physical Status II-III
- •Signed written consent form
- •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 1500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 780
排除标准
- •Hypersensitivity to the active substances or to any of the other excipients of the investigational products
- •Body weight = 140 kg
- •Renal impairment (AKIN stage = 1 or chronic) or acute and/or chronic renal replacement therapy
- •Intracranial or cerebral haemorrhage
- •Critically ill patients (typically admitted to the intensive care unit)
- •Dehydration
- •Hyperhydration
- •Pulmonary oedema
- •Congestive heart failure
- •Severe hypernatraemia,
- •Severe hyperchloraemia
- •Hyperkalaemia
- •Metabolic alkalosis
- •Severely impaired hepatic function
- •Severe coagulopathy
- •Organ transplant patients
- •Simultaneous participation in another interventional trial (drugs or medical device)
研究者
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