NCT02670239

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Last Updated

February 1, 2016

Status Verified

January 1, 2016

Enrollment Period

3.7 years

First QC Date

January 22, 2016

Last Update Submit

January 27, 2016

Conditions

Lung Transplantation

Outcome Measures

Primary Outcomes (1)

  • imipenem concentration

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

    change from baseline in imipenem concentration at 6 hours

Secondary Outcomes (6)

  • pathogens isolated from donors

    48 hours before lung procurement

  • pathogens isolated from recipients

    48 hours after lung transplantation

  • Clinical Pulmonary Infection Score

    at 72 hours after lung transplantation

  • Primary graft dysfunction

    at 72 hours after lung transplantation

  • Days of mechanical ventilation

    at 28 days

  • +1 more secondary outcomes

Study Arms (1)

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

normothermic ex vivo lung perfusionPROCEDURE
EVLP group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Best PaO2/FiO2 \< 300 mmHg;
  • Pulmonary edema on chest X-Ray;
  • Poor inflation or deflation at visual inspection;
  • Need for blood transfusion of more than 10U;
  • Maastricht category III/IV

You may not qualify if:

  • Diagnosis of pneumonia;
  • severe mechanical injury;
  • gross gastric aspiration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Turin - Azienda Ospedaliera Città della Salute e della Scienza di Torino

Turin, Turin, 10126, Italy

RECRUITING

Central Study Contacts

Vito Fanelli, MD, PhD

CONTACT

0039011633vito.fanelli@unito.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 22, 2016

First Posted

February 1, 2016

Study Start

May 1, 2014

Primary Completion

January 1, 2018

Last Updated

February 1, 2016

Record last verified: 2016-01

Locations

IT(1)