Pharmacokinetics of Imipenem During Ex Vivo Lung Perfusion (EVLP)

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.

Study Overview

• Status: Unknown
• Conditions: Lung Transplantation
• Intervention / Treatment: Procedure: normothermic ex vivo lung perfusion

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Vito Fanelli, MD, PhD; Phone Number: 4005 0039011633; Email: vito.fanelli@unito.it

Study Locations

• Italy
  • Turin, Italy, 10126
    • Recruiting
    • University of Turin - Azienda Ospedaliera Città della Salute e della Scienza di Torino
    • Contact: Vito Fanelli, MD, PhD; Phone Number: 4005 0039011633; Email: vito.fanelli@unito.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

lungs from brain dead donors that were considered at high-risk for transplantation and underwent EVLP

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
imipenem concentration	concentration of imipenem in lung perfusate and in lung biopsy during EVLP	change from baseline in imipenem concentration at 6 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
pathogens isolated from donors	48 hours before lung procurement
pathogens isolated from recipients	48 hours after lung transplantation
Clinical Pulmonary Infection Score	at 72 hours after lung transplantation
Primary graft dysfunction	at 72 hours after lung transplantation
Days of mechanical ventilation	at 28 days
Intensive Care Unit length of stay	at day 28

Collaborators and Investigators

• Sponsor: University of Turin, Italy

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Anticipated): January 1, 2018
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: January 22, 2016
• First Submitted That Met QC Criteria: January 27, 2016
• First Posted (Estimate): February 1, 2016

Study Record Updates

• Last Update Posted (Estimate): February 1, 2016
• Last Update Submitted That Met QC Criteria: January 27, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: CEI-178

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No