NCT01418521Unknown4 期
Safety and Effectiveness of a Balanced 3rd Generation HES Solution (Tetraspan®) Versus Albumin Solution for Volume Replacement in Patients After Cardiac Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Chest tube drainage volume
研究概览
简要总结
The purpose of this randomized controlled trial in patients undergoing cardiac surgery is to show that a 3rd generation HES (Hydroxyethyl Starch) solution - Tetraspan® is as good as in terms of safety and effectiveness as the commonly used albumin based solution for volume replacement after the surgery.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be obtained from the subject or his/her legal guardian before any assessment is performed.
- •Male or Female subject, 18 years or older.
- •Any elective cardiac surgery
排除标准
- •Subjects with impaired liver function defined as an elevated level of ALT and AST over 100 U/L.
- •Hyperhydration states (e.g. pulmonary edema, congestive heart failure).
- •Renal failure with creatinine blood levels > 2.5 mg/dL or eGFR < 30 ml/min (calculated using the DMRD formula).
- •Oliguria (UO<0.5ml\kg\hr) or anuria (not related to hypovolemia) more than 12 hours.
- •Current Intracranial hemorrhage.
- •Current, hard to balance hyperkalemia.
- •Severe hypernatremia or severe hyperchloremia.
- •Known hypersensitivity to hydroxyethyl starch or to any of the excipients.
研究组 & 干预措施
Ringer-albumin
Active Comparator
Patients receiving the standard care of ringer-albumin as volume replacement after cardiac surgery
干预措施: Ringer- albumin (Drug)
Tetraspan
Experimental
patients receiving a 3rd generation HES solution (tetraspan) for volume replacement after cardiac surgery
干预措施: Balanced hydroxyethyl starch solution (Drug)
结局指标
主要结局
Chest tube drainage volume
时间窗: Total volume at the time of removal of drains (48 hours after surgery on average)
次要结局
- In hospital - all cause mortality(End of hospitalization (5 days postsurgery on average))
- Volume of replacement fluids given after surgery at each group(Summary of volume replacement at the time of discharge from ICU (48 hours after surgery on average))
- 30-days all cause mortality(30 days from surgery)
- Incidence of kidney injury as defined by RIFLE criteria(Duration of hospitalization after surgery (expected average duration of 5 days))
- Incidence of coagulopathy as defined by prolonged PT\PTT and abnormal thromboelastogram not due to clotting inhibitors during hospitalization.(Duration of hospitalization after surgery (expected average duration of 5 days))
- Volume of Transfused blood products during hospitalization postsurgery(Duration of hospitalization after surgery (expected average duration of 5 days))
研究者
研究点 (1)
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