Lung Transplantation
Conditions
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.
Interventions
PROCEDUREnormothermic ex vivo lung perfusion
Sponsors
University of Turin, Italy
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| imipenem concentration | change from baseline in imipenem concentration at 6 hours | concentration of imipenem in lung perfusate and in lung biopsy during EVLP |
Secondary
| Measure | Time frame |
|---|---|
| pathogens isolated from recipients | 48 hours after lung transplantation |
| Clinical Pulmonary Infection Score | at 72 hours after lung transplantation |
| pathogens isolated from donors | 48 hours before lung procurement |
| Days of mechanical ventilation | at 28 days |
| Intensive Care Unit length of stay | at day 28 |
| Primary graft dysfunction | at 72 hours after lung transplantation |
Countries
Italy
Contacts
Primary ContactVito Fanelli, MD, PhD
Outcome results
None listed