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Trial record 8 of 20 for:    evlp

Pharmacokinetics of Imipenem During Ex Vivo Lung Perfusion (EVLP)

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ClinicalTrials.gov Identifier: NCT02670239
Recruitment Status : Unknown
Verified January 2016 by Vito Fanelli MD, PhD, University of Turin, Italy.
Recruitment status was:  Recruiting
First Posted : February 1, 2016
Last Update Posted : February 1, 2016
Sponsor:
Information provided by (Responsible Party):
Vito Fanelli MD, PhD, University of Turin, Italy

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
Lung Transplantation Procedure: normothermic ex vivo lung perfusion

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : May 2014
Estimated Primary Completion Date : January 2018

Resource links provided by the National Library of Medicine


Group/Cohort 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



Primary Outcome Measures :
  1. imipenem concentration [ Time Frame: 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 [ 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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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670239


Contacts
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Contact: Vito Fanelli, MD, PhD 0039011633 ext 4005 vito.fanelli@unito.it

Locations
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Italy
University of Turin - Azienda Ospedaliera Città della Salute e della Scienza di Torino Recruiting
Turin, Italy, 10126
Contact: Vito Fanelli, MD, PhD    0039011633 ext 4005    vito.fanelli@unito.it   
Sponsors and Collaborators
University of Turin, Italy

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Responsible Party: Vito Fanelli MD, PhD, MD, PhD, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT02670239     History of Changes
Other Study ID Numbers: CEI-178
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: February 1, 2016
Last Verified: January 2016