Pharmacokinetics of Imipenem During Ex Vivo Lung Perfusio... | NCT02670239

Studies
Pharmacokinetics of Imipenem During Ex Vivo Lung Perfusion (EVLP)

NCT02670239

Sponsor

University of Turin, Italy

Status

Unknown status

Last Update Posted

Feb 1, 2016Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Lung Transplantation

Interventions

normothermic ex vivo lung perfusion

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Jan 2018Estimated

Completion Date

Not provided

First Submitted Date

Jan 22, 2016

First Submission Date that Met QC Criteria

Jan 27, 2016

First Posted Date

Feb 1, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2016

Last Update Posted Date

Feb 1, 2016Estimated

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
normothermic ex vivo lung perfusion	Procedure		EVLP group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
pathogens isolated from donors		48 hours before lung procurement
pathogens isolated from recipients		48 hours after lung transplantation
Clinical Pulmonary Infection Score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Diagnosis of pneumonia;
severe mechanical injury;
gross gastric aspiration

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vito Fanelli, MD, PhD	Contact	0039011633	4005	vito.fanelli@unito.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Turin - Azienda Ospedaliera Città della Salute e della Scienza di Torino	Recruiting	Turin	Turin	10126	Italy