Morphofunctional Lung Analysis by PET and CT After Lung Transplantation
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.
Disorder Related to Lung Transplantation
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Morphofunctional Lung Analysis by Positron Emission Tomography and Computed Tomography After Lung Transplantation|
- Number of patients alive [ Time Frame: up to 90 days from transplantation ] [ Designated as safety issue: No ]
- incidence of complications other than primary graft dysfunction [ Time Frame: 72 hours and 90 days ] [ Designated as safety issue: Yes ]
- incidence of primary graft dysfunction [ Time Frame: 72 hours and 90 days after transplantation ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2013|
|Study Completion Date:||January 2016|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Lung transplantated patients
Patients undergone lung transplantation
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01746914
|Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico|
|Milano, Milan, Italy, 20122|
|Principal Investigator:||Davide Chiumello, MD||Policlinico Hospital|
|Principal Investigator:||Franco Valenza, MD||Policlinico Hospital|