NL-OMON53031已完成4 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
PRA Belgium BV0 个研究点目标入组 350 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 350
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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 informed consent
排除标准
- •* Hypersensitivity to the active substances or to any of the other excipients
- •of the investigational
- •* medicinal products* Body weight * 140 kg* Sepsis* Burns* 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)* Hyperhydration* Pulmonary oedema*
- •Dehydration* Hyperkalaemia* Severe hypernatraemia* Severe hyperchloraemia*
- •Severely impaired hepatic function* Congestive heart failure* Severe
- •coagulopathy* Organ transplant patients* Metabolic alkalosis* Simultaneous
- •participation in another interventional trial (drugs or medical device)
- •cacy of HES-containing solutions with re
研究者
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