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Completed

NCT Number: NCT01746914

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.

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Key information

Conditions

Disorder Related to Lung Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • lung transplantation
  • ≥ 18 years

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Number of patients alive

    Time frame: up to 90 days from transplantation

Secondary outcomes

  1. incidence of complications other than primary graft dysfunction

    Time frame: 72 hours and 90 days

  2. incidence of primary graft dysfunction

    Time frame: 72 hours and 90 days after transplantation

Sponsors and collaborators

Lead sponsor

Policlinico Hospital

Other

Registry information

Official study title

Morphofunctional Lung Analysis by Positron Emission Tomography and Computed Tomography After Lung Transplantation

Important dates

Study start
2013
Primary completion
2014
Study completion
2016
First posted
Dec 11, 2012
Registry last updated
Mar 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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