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临床试验/NCT01746914
NCT01746914已完成不适用

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

Policlinico Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Number of patients alive

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • lung transplantation
  • ≥ 18 years

排除标准

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

结局指标

主要结局

Number of patients alive

时间窗: up to 90 days from transplantation

次要结局

  • incidence of complications other than primary graft dysfunction(72 hours and 90 days)
  • incidence of primary graft dysfunction(72 hours and 90 days after transplantation)

研究者

发起方
Policlinico Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Davide Chiumello

MD

Policlinico Hospital

研究点 (1)

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