EUCTR2020-002756-21-AT进行中（未招募）1 期
Plasma Pharmacokinetics of Prophylactic Cefazolin Administered for Cardiac Surgery: Comparison of Cardiopulmonary Bypass Priming with Additive Human Albumin 20% vs.Pure Crystalloid Priming: A single center, prospective, randomized and controlled trial - HLM_Albumin
Department of Cardiothoracic Anesthesia and Intensive Care Medicine, Medical University of Vienna0 个研究点目标入组 40 人开始时间: 2021年1月14日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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
- •Written informed consent
- •Patients undergoing elective aortic valve repair
- •Patients undergoing elective mitral valve repair
- •Patients undergoing elective coronary artery bypass grafting
- •Age: 18 – 85 years of age
- •BMI: 20 -35 kg/m2
- •No former allergic reaction to albumin
- •No former allergic reaction to cefazolin
- •Ejection fraction > 25%
- •No former cardiac surgery
- •Hemoglobin concentration > 11 mg/dL prior to surgery
- •Serum creatinin < 2 mg/dL
- •No significant hepatic disease (liver function tests < 3 X upper limit of normal)
- •No history of coagulation disorders
- •No signs of local or systemic infection
- •No antibiotic therapy within the last 3 days
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •No informed consent
- •Emergency cardiac surgery
- •History of hypersensitivity to ß-lactam antibiotics
- •History of allergic reaction to albumin
- •Infection at site of surgery
- •Systemic infection (endocarditis)
- •Antimicrobial therapy within 3 days of surgery
- •Former cardiac surgery
- •Hemoglobin concentration < 11 mg/dL prior to surgery
- •Congestive heart failure with ejection fraction < 25%
- •Significant hepatic disease (liver function tests < 3 X upper limit of normal)
- •Renal impairment with serum creatinine > 2 mg/L and/or GFR <60mL/min
- •Body Mass Index (BMI) < 20 kg/m2 or BMI > 35 kg/m2
- •Pregnancy or missing pregnancy test
- •Perioperative need of Levosimendan (will lead to drop out)
- •Aortic clamping time >240 minutes (will lead to drop out)
- •Extra corporal circuit time >400 minutes (will lead to drop out)
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