Pharmacokinetics of Imipenem During Ex Vivo Lung Perfusion (EVLP)

• Conditions: Lung Transplantation
• Interventions: Procedure: normothermic ex vivo lung perfusion

• Registration Number: NCT02670239
• Lead Sponsor: University of Turin, Italy

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Status Verified: 2016-01
• Study First Submitted: 2016-01-22
• Study First Submitted QC: 2016-01-27
• Last Update Submitted: 2016-01-27
• Study First Posted: 2016-02-01
• Last Update Posted: 2016-02-01
• Primary Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Best PaO2/FiO2 < 300 mmHg;
2. Pulmonary edema on chest X-Ray;
3. Poor inflation or deflation at visual inspection;
4. Need for blood transfusion of more than 10U;
5. Maastricht category III/IV

Exclusion Criteria

1. Diagnosis of pneumonia;
2. severe mechanical injury;
3. gross gastric aspiration

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EVLP group	normothermic ex vivo lung perfusion	All lungs from brain dead donors that were considered at high-risk for transplantation and underwent EVLP in the Turin lung transplantation program

Primary Outcome Measures

Name	Time	Method
imipenem concentration	change from baseline in imipenem concentration at 6 hours	concentration of imipenem in lung perfusate and in lung biopsy during EVLP

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Turin - Azienda Ospedaliera Città della Salute e della Scienza di Torino; 🇮🇹 Turin, Italy