2024-518338-10-00招募中4 期
The Effect of Albumin Levels on Pharmacokinetics of Cefazolin in Adult Cardiac Surgery: A Prospective, Randomized, Open-label, Parallel-group Pharmacokinetic Study
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The area under the concentration-time curve from 0 - 10h (AUC0-10 ) for free + total drug will be compared between the control and intervention group.
研究概览
简要总结
Primary objective: The area under the concentration-time curve from 0 - 10h (AUC0-10 ) for free and total drug will be compared between the control and intervention group.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •written informed consent
- •Planned use of cardiopulmonary bypass
- •Age: > 18 and < 90 years
- •Ejection fraction > 40%
排除标准
- •Inability to give informed consent
- •Long standing diabetes mellitus (> 7 years) and insulin-dependent diabetes mellitus
- •Pregnant women
- •The standardized priming solution (1500ml Ringer’s Lactate, 100ml Mannit 20% and 10.000IE Heparin) is deemed inappropriate according to the treating physicians
- •Known allergy to penicillin/cephalosporins or cefazolin
- •Preoperative antibiotic therapy
- •Preoperative serum albumin concentration <40g/L
- •Emergency procedure
- •Preoperative renal failure
- •Chronic severe renal insufficiency including hemodialysis
- •Chronic severe liver disease
结局指标
主要结局
The area under the concentration-time curve from 0 - 10h (AUC0-10 ) for free + total drug will be compared between the control and intervention group.
The area under the concentration-time curve from 0 - 10h (AUC0-10 ) for free + total drug will be compared between the control and intervention group.
次要结局
未报告次要终点
研究者
Division of Cardiac Thoracic Vascular Anaesthesia and Intensive Care Medicine
Scientific
Medical University Of Vienna
研究点 (1)
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