Pharmacokinetics of Imipenem During Ex Vivo Lung Perfusion (EVLP)

University of Turin

Status: Unknown

Conditions: Lung Transplantation

Treatments: Procedure: normothermic ex vivo lung perfusion

Study type: Observational

Funder types: Other

Identifiers

NCT02670239

CEI-178

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

EVLP group

Description:

All lungs from brain dead donors that were considered at high-risk for transplantation and underwent EVLP in the Turin lung transplantation program

Treatment:

Procedure: normothermic ex vivo lung perfusion