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临床试验/NCT06583642
NCT06583642尚未招募不适用

Antimicrobial Therapeutic Drug Monitoring During Lung Transplant Perioperative Phase

Policlinico Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
Plasma Antimicrobial Concentration

研究概览

简要总结

Background: Post-LUTX pneumonia represents a leading cause of death along the first month after LUTX. Donor-derived transmission of pathogenic species occurs up to 25% of recipients receiving a graft with a positive BAL culture, despite in-vitro adequate antimicrobial prophylaxis.

Hypothesis: LUTX recipients are either exposed to suboptimal antimicrobial doses or antimicrobial penetration into the lug parenchyma is altered either due to surgery (absence of bronchial anastomoses) or to the hyperinflammatory state.

Methods: LUTX recipients admitted to the intensive care unit at the Fondazione IRCCS Ca' Granda Policlinico Hospital. According to the institutional perioperative prophylaxis protocol and the donor/recipient ecology the most frequent antimicrobial molecules administered will be: cefepime, vancomycin, and meropenem. Antimicrobial pharmacokinetics will be investigated at three timepoints. Plasma levels of the ongoing antimicrobial molecule will be assessed at ICU admission, on postoperative day 1 and on postoperative day 3. Bronchoalveolar lavage (BAL) samples for the measurement of BAL antimicrobial levels will be collected during the BAL performed for clinical indication on postoperative day 1 and on postoperative day 3.

Absolute plasma and BAL antimicrobial levels will be assessed. The ratio of BAL to plasma dosage of antimicrobial will be assessed to evaluate antimicrobial penetration within the target tissue. Correlation between both plasma and BAL antimicrobial dosage and recipients' postoperative fluid balance, body weight, vasopressor requirement, renal function will be performed.

详细描述

  1. BACKGROUND

Lung Transplantation (LUTX) is the curative treatment for selected patients with end-stage lung disease. Despite continuous optimization of recipients perioperative phase morbidity and mortality remain about 20%. Bacterial infections are a leading cause of death in the early post-transplant period.

Donor-recipient transmission of pathogens plays an actual role in worsening graft function. The rate of donor with bacterial growth on the pre-LUTX bronchoalveolar lavage (BAL) is high (36%).Furthermore, among uncolonized recipients, receiving a graft with a positive BAL carries the risk of developing a donor-derived infection (DDI) in almost one quarter of cases, affecting early graft function, despite recipients were already treated with an "in-vitro appropriate" antibiotic therapy. In this scenario, the adequacy of perioperative antimicrobial prophylaxis might play a major in preventing either donor derived pulmonary or surgical site infections.

Aim of the present study is to describe the PK of the most frequently used perioperative antimicrobials (i.e., cefepime, meropenem, and vancomycin) in plasma and in the bronchoalveolar lavage of patients undergoing double LUTX during the immediate postoperative phase. 2. HYPOTHESIS of the study

Hypothesis of the study is that LUTX recipients are either exposed to suboptimal antimicrobial doses or antimicrobial penetration into the lug parenchyma is altered either due to surgery (absence of bronchial anastomoses) or to the hyperinflammatory state.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Recipient of LUTX
  • Age > 18 years
  • Signed informed consent

排除标准

  • Age < 18 years old
  • Already undergone LUTX
  • Documented respiratory colonization in the 12 months preceding LUTX
  • Undergoing any antimicrobial therapy preceding LUTX
  • Documented post-LUTX endobronchial plasma leak requiring high levels of PEEP > 15 cmH2O.

结局指标

主要结局

Plasma Antimicrobial Concentration

时间窗: ICU admission after LuTX; 12 hours after LuTX; 72 hours after LuTX

Dosage of plasma levels of Cefepime or Meropenem or Vancomycin

Bronchoalveolar Antimicrobial Concentration

时间窗: ICU admission after LuTX; 12 hours after LuTX; 72 hours after LuTX

Dosage of bronchoalveolar levels of Cefepime or Meropenem or Vancomycin

Antimicrobial lung tissue penetration

时间窗: ICU admission after LuTX; 12 hours after LuTX; 72 hours after LuTX

Ratio of bronchoalveolar to plasma concentration of Cefepime or Meropenem or Vancomycin

次要结局

未报告次要终点

研究者

发起方
Policlinico Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giacomo Grasselli

MD

Policlinico Hospital

研究点 (1)

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