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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

Tracking Information
First Submitted Date January 22, 2016
First Posted Date February 1, 2016
Last Update Posted Date February 1, 2016
Study Start Date May 2014
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 27, 2016)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 27, 2016)
  • pathogens isolated from donors [ Time Frame: 48 hours before lung procurement ]
  • pathogens isolated from recipients [ Time Frame: 48 hours after lung transplantation ]
  • Clinical Pulmonary Infection Score [ Time Frame: at 72 hours after lung transplantation ]
  • Primary graft dysfunction [ Time Frame: at 72 hours after lung transplantation ]
  • Days of mechanical ventilation [ Time Frame: at 28 days ]
  • Intensive Care Unit length of stay [ Time Frame: at day 28 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pharmacokinetics of Imipenem During Ex Vivo Lung Perfusion (EVLP)
Official Title Not Provided
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population lungs from brain dead donors that were considered at high-risk for transplantation and underwent EVLP
Condition Lung Transplantation
Intervention Procedure: normothermic ex vivo lung perfusion
Study Groups/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
Intervention: Procedure: normothermic ex vivo lung perfusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 27, 2016)
30
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT02670239
Other Study ID Numbers CEI-178
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Vito Fanelli MD, PhD, University of Turin, Italy
Study Sponsor University of Turin, Italy
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Turin, Italy
Verification Date January 2016