Lung TransplantationNCT02670239
Pharmacokinetics of Imipenem During Ex Vivo Lung Perfusion (EVLP)
An observational study of Lung Transplantation, run by University of Turin, Italy at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Transplantation
- What is being tested?
- normothermic ex vivo lung perfusion
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- May 2014to Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: lungs from brain dead donors that were considered at high-risk for transplantation and underwent EVLP
Who may be able to join
- 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
Who cannot join
- Diagnosis of pneumonia;
- severe mechanical injury;
- gross gastric aspiration
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Turin - Azienda Ospedaliera Città della Salute e della Scienza di Torino
Turin, Turin, 10126
Vito Fanelli, MD, PhD, 0039011633 ext. 4005, vito.fanelli@unito.it
About this study
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.
- Conditions
- Lung Transplantation
- Being tested
- normothermic ex vivo lung perfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normothermic ex vivo lung perfusionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: normothermic ex vivo lung perfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
imipenem concentration
concentration of imipenem in lung perfusate and in lung biopsy during EVLP
Measured: change from baseline in imipenem concentration at 6 hours
Secondary outcomes (6)
pathogens isolated from donors
Measured: 48 hours before lung procurement
pathogens isolated from recipients
Measured: 48 hours after lung transplantation
Clinical Pulmonary Infection Score
Measured: at 72 hours after lung transplantation
Primary graft dysfunction
Measured: at 72 hours after lung transplantation
Days of mechanical ventilation
Measured: at 28 days
Intensive Care Unit length of stay
Measured: at day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study startMay 2014
- Primary completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vito Fanelli MD, PhD, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670239
- Sponsor's protocol ID
- CEI-178
- Status last verified
- Jan 2016
- First submitted
- 22 Jan 2016
- Last updated
- 1 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Imipenem During Ex Vivo Lung Perfusion (EVLP)
- ClinicalTrials.gov ID
- NCT02670239
- Acronym / sponsor ID
- CEI-178
- Conditions
- Lung Transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jan 2018 (estimated)
- First posted
- 1 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EVLP group | – | Procedure: normothermic ex vivo lung perfusionAll lungs from brain dead donors that were considered at high-risk for transplantation and underwent EVLP in the Turin lung transplantation program |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- lungs from brain dead donors that were considered at high-risk for transplantation and underwent EVLP
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Diagnosis of pneumonia;
- severe mechanical injury;
- gross gastric aspiration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| normothermic ex vivo lung perfusion | Procedure or surgery | EVLP group |
Primary outcome
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
6 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplantation, run by University of Turin, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vito Fanelli, MD, PhD (0039011633 ext. 4005, vito.fanelli@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
imipenem concentration (time frame: change from baseline in imipenem concentration at 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2016.