Morphofunctional Lung Analysis by PET and CT After Lung Transplantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Davide Chiumello, Policlinico Hospital
ClinicalTrials.gov Identifier:
NCT01746914
First received: December 7, 2012
Last updated: March 29, 2016
Last verified: March 2016

December 7, 2012
March 29, 2016
January 2013
July 2014   (final data collection date for primary outcome measure)
Number of patients alive [ Time Frame: up to 90 days from transplantation ] [ Designated as safety issue: No ]
mortality [ Time Frame: up to 90 days from transplantation ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01746914 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Morphofunctional Lung Analysis by PET and CT After Lung Transplantation
Morphofunctional Lung Analysis by Positron Emission Tomography and Computed Tomography 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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Lung Transplantated patients
Disorder Related to Lung Transplantation
Not Provided
Lung transplantated patients
Patients undergone lung transplantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
January 2016
July 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • lung transplantation
  • ≥ 18 years

Exclusion Criteria:

  • < 18 years
  • patient' s clinical conditions not allowing patient transport from ICU to Nuclear Medicine Unit
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01746914
201212
No
Undecided
Not Provided
Davide Chiumello, Policlinico Hospital
Policlinico Hospital
Not Provided
Principal Investigator: Davide Chiumello, MD Policlinico Hospital
Principal Investigator: Franco Valenza, MD Policlinico Hospital
Policlinico Hospital
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP