Morphofunctional Lung Analysis by PET and CT After Lung Transplantation

NCT ID: NCT01746914

Last Updated: 2016-03-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2016-01-31

Brief Summary

72 hours after lung transplantation, patients undergo a positron emission tomography (PET) scan and a computed tomography (CT) scan in order to analyse lung function and morphology.

Aim of the study is to analyse complications onset (in particular primary graft dysfunction), and evaluate 90 days mortality after lung transplantation.

Detailed Description

Pulmonary transplantation is considered as a lifesaving procedure in end-stage pulmonary disease. However morbidity and mortality after lung transplantation are still significant.

Primary graft dysfunction (PGD) is the main cause of early death. PGD is similar to acute lung injury (ALI)/ acute respiratory distress syndrome (ARDS): oxygenation is compromised, pulmonary compliance is decreased, chest Rx shows several infiltrates, and alveolar damage is present.

25% of patients develops PGD within 72 hours from transplantation and 30 days mortality is eight times higher in patients who develop PGD.

72 hours after lung transplantation, patients, whose clinical condition allow to bring them to nuclear medicine department, will undergo pulmonary computed tomography (CT) to study lung morphology and measure lung recruitability and positron emission tomography (PET) to study lung functionality and estimate lung inflammation.

Aim of this study is to investigate the onset of PGD and other complications and to determine 72 hours and 90 days mortality after lung transplantation.

Conditions

Disorder Related to Lung Transplantation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Lung transplantated patients

Patients undergone lung transplantation

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• lung transplantation
• ≥ 18 years

Exclusion Criteria

• < 18 years
• patient' s clinical conditions not allowing patient transport from ICU to Nuclear Medicine Unit

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Policlinico Hospital

OTHER

Sponsor Role: lead

Responsible Party

Davide Chiumello

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Davide Chiumello, MD

Role: PRINCIPAL_INVESTIGATOR

Policlinico Hospital

Franco Valenza, MD

Role: PRINCIPAL_INVESTIGATOR

Policlinico Hospital

Locations

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Milan, Italy

Countries

Italy

Other Identifiers

201212

Identifier Type: -

Identifier Source: org_study_id