Pharmacokinetics of Imipenem During Ex Vivo Lung Perfusion (EVLP)

• Sponsor: University of Turin, Italy (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02670239
• Collaborator: (none)
• Enrollment: 30
• Location: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Transplantation	Procedure: normothermic ex vivo lung perfusion

Study Design

• Study Type: Observational
• Anticipated Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Study Start Date: May 1, 2014
• Anticipated Primary Completion Date: Jan 1, 2018

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. imipenem concentration [change from baseline in imipenem concentration at 6 hours]

   concentration of imipenem in lung perfusate and in lung biopsy during EVLP

Secondary Outcome Measures

1. pathogens isolated from donors [48 hours before lung procurement]

2. pathogens isolated from recipients [48 hours after lung transplantation]

3. Clinical Pulmonary Infection Score [at 72 hours after lung transplantation]

4. Primary graft dysfunction [at 72 hours after lung transplantation]

5. Days of mechanical ventilation [at 28 days]

6. Intensive Care Unit length of stay [at day 28]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Turin - Azienda Ospedaliera Città della Salute e della Scienza di Torino	Turin		Italy	10126

Sponsors and Collaborators

• University of Turin, Italy

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vito Fanelli MD, PhD, MD, PhD, University of Turin, Italy
• ClinicalTrials.gov Identifier: NCT02670239
• Other Study ID Numbers: CEI-178
• First Posted: Feb 1, 2016
• Last Update Posted: Feb 1, 2016
• Last Verified: Jan 1, 2016

Study Results

No Results Posted as of Feb 1, 2016