Pharmacokinetics of Imipenem During Ex Vivo Lung Perfusion (EVLP)

Lung Transplantation Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02670239
• Other study ID #: CEI-178
• Status: Recruiting
• Phase: N/A
• First received: January 22, 2016
• Last updated: January 27, 2016
• Start date: May 2014

Study information

• Verified date: January 2016
• Source: University of Turin, Italy
• Contact: Vito Fanelli, MD, PhD
• Phone: 0039011633
• Email: vito.fanelli[@]unito.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Transplantation

Intervention

Procedure:
• normothermic ex vivo lung perfusion

Locations

Country	Name	City	State
Italy	University of Turin - Azienda Ospedaliera Città della Salute e della Scienza di Torino	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	imipenem concentration	concentration of imipenem in lung perfusate and in lung biopsy during EVLP	change from baseline in imipenem concentration at 6 hours	No
Secondary	pathogens isolated from donors		48 hours before lung procurement	No
Secondary	pathogens isolated from recipients		48 hours after lung transplantation	No
Secondary	Clinical Pulmonary Infection Score		at 72 hours after lung transplantation	No
Secondary	Primary graft dysfunction		at 72 hours after lung transplantation	No
Secondary	Days of mechanical ventilation		at 28 days	No
Secondary	Intensive Care Unit length of stay		at day 28	No