NCT02670239Unknown不适用
Pharmacokinetics of Imipenem During Ex Vivo Lung Perfusion (EVLP)
University of Turin, Italy1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- imipenem concentration
研究概览
简要总结
Ex vivo lung perfusion (EVLP) is an established strategy to evaluate and optimize high-risk donor lungs that would otherwise be rejected for transplantation mainly due to the presence of edema or infection. Extracorporeal circuits may negatively affects pharmacokinetic (PK) of several drugs including antibiotics, thus exposing patients to risk of therapeutic failure or drug toxicity. The investigators set out to examine the concentration of imipenem in lung perfusate and in lung biopsy during EVLP, and its clinical impact.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Best PaO2/FiO2 < 300 mmHg;
- •Pulmonary edema on chest X-Ray;
- •Poor inflation or deflation at visual inspection;
- •Need for blood transfusion of more than 10U;
- •Maastricht category III/IV
排除标准
- •Diagnosis of pneumonia;
- •severe mechanical injury;
- •gross gastric aspiration
结局指标
主要结局
imipenem concentration
时间窗: change from baseline in imipenem concentration at 6 hours
concentration of imipenem in lung perfusate and in lung biopsy during EVLP
次要结局
- pathogens isolated from donors(48 hours before lung procurement)
- Primary graft dysfunction(at 72 hours after lung transplantation)
- Days of mechanical ventilation(at 28 days)
- Clinical Pulmonary Infection Score(at 72 hours after lung transplantation)
- pathogens isolated from recipients(48 hours after lung transplantation)
- Intensive Care Unit length of stay(at day 28)
研究者
Vito Fanelli MD, PhD
MD, PhD
University of Turin, Italy
研究点 (1)
Loading locations...
相似试验
Unknown
4 期
Imipenem in Critically Ill PatientsCritically Ill Patients With ECMONCT03776305Prince of Songkla University12
已完成
1 期
Normothermic Ex Vivo Lung Perfusion (EVLP) For An Improved Assessment of Donor Lungs For TransplantationLung TransplantationNCT01190059XVIVO Perfusion22
已完成
不适用
Ex Vivo Lung Perfusion in Bergamo Lung Transplant ProgramEx Vivo Lung PerfusionLung TransplantationNCT03053349Papa Giovanni XXIII Hospital10
招募中
不适用
Use of Ex Vivo Lung Perfusion (EVLP) in Reconditioning Marginal Donor Lungs for TransplantationLung TransplantNCT02235610Centre hospitalier de l'Université de Montréal (CHUM)50
已完成
1 期
Imipenem/Cilastatin/Relebactam PK in ECMOSepsisNCT04493151Joseph L. Kuti, PharmD8