Pharmacokinetics of Imipenem During Ex Vivo Lung Perfusion (EVLP)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Lung Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

normothermic ex vivo lung perfusion

Intervention Type PROCEDURE

Interventions

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normothermic ex vivo lung perfusion

Intervention Type PROCEDURE

Eligibility Criteria

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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