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Status unknownNCT02670239Updated Feb 1, 2016

Pharmacokinetics of Imipenem During Ex Vivo Lung Perfusion (EVLP)

An observational study in Lung Transplantation, sponsored by University of Turin, Italy. Status unknown at 1 site in Italy. Per ClinicalTrials.gov, last updated 2016-02-01.

Sponsored by University of Turin, Italy · Observational

The sponsor has not verified this record recently (last verified Jan 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Sex
All
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Study 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.

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Conditions studied

  • Lung Transplantation
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In context

Lead sponsor

University of Turin, Italy is the lead sponsor of 206 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

lungs from brain dead donors that were considered at high-risk for transplantation and underwent EVLP

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

Exclusion Criteria:

  1. Diagnosis of pneumonia;
  2. severe mechanical injury;
  3. gross gastric aspiration
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • Procedurenormothermic ex vivo lung perfusion
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What researchers measure

Primary outcomes

  1. imipenem concentration

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

    Time frame: change from baseline in imipenem concentration at 6 hours

Secondary outcomes

  1. pathogens isolated from donors

    Time frame: 48 hours before lung procurement

  2. pathogens isolated from recipients

    Time frame: 48 hours after lung transplantation

  3. Clinical Pulmonary Infection Score

    Time frame: at 72 hours after lung transplantation

  4. Primary graft dysfunction

    Time frame: at 72 hours after lung transplantation

  5. Days of mechanical ventilation

    Time frame: at 28 days

  6. Intensive Care Unit length of stay

    Time frame: at day 28

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Study locations

1 of 1 sites recruiting
  • University of Turin - Azienda Ospedaliera Città della Salute e della Scienza di Torino
    Turin, 10126, Italy
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02670239
Lead sponsor
University of Turin, Italy
Responsible party
Vito Fanelli MD, PhD (MD, PhD, University of Turin, Italy) — Principal investigator
First posted
Feb 1, 2016
Start date
May 2014
Primary completion
Jan 2018 (estimated)
Last update
Feb 1, 2016

Study contacts

Vito Fanelli, MD, PhD
Contact
vito.fanelli@unito.it
0039011633 ext. 4005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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