跳至主要内容
临床试验/NCT03919604
NCT03919604已完成不适用

Extracorporeal Membrane Oxygenation for Lung Transplantation in Cystic Fibrosis Patients: Predictors and Impact on Outcome

Policlinico Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2013年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Length of mechanical ventilation

研究概览

简要总结

Cystic fibrosis (CF) is the most common genetically inherited disease in the Caucasian population. Bilateral lung transplantation (LUTX) is a viable option for these patients.

Frequently, the surgical operation of LUTX is complicated by hemodynamic instability, intractable hypoxia and respiratory acidosis. For these reasons, Intraoperative extracorporeal life support - ECLS- is required. Data on predictors of use of intraoperative ECLS in CF patients undergoing LUTX is scarce. Aim of this retrospective observational study was 1) to find possible risk factors at the time of enlistment associated with the intraoperative use of ECLS and 2) to compare the outcomes of CF patients treated with ECLS during LUTX or not.

详细描述

Cystic fibrosis (CF) is the most common genetically inherited disease in the Caucasian population and damages multiple organ systems (i.e., upper and lower respiratory tract, pancreas, liver). Respiratory manifestations include reduction of mucus clearance, chronic pulmonary infections and bronchiectasis, causing progressive respiratory failure that is the primary cause of death in CF patients. Moreover, advanced CF is complicated by pulmonary hypertension, right ventricular hypertrophy and right heart failure. Bilateral lung transplantation (LUTX) is a viable option for these patients, providing a significant survival benefit as compared to no-LuTX.

Frequently, the surgical operation of LUTX is complicated by acute heart failure (due to sequential pulmonary artery cross-clamping and/or hemodynamic instability), severe intractable hypoxia and respiratory acidosis. For these reasons, extracorporeal life support - ECLS - (either in the form of cardiopulmonary bypass -CBP- or extracorporeal membrane oxygenation -ECMO) is frequently required.

To now, literature data on predictors of use of intraoperative ECLS in CF patients undergoing LUTX is scarce. Notably, the use of ECLS during LUTX has been associated with a higher risk of primary graft dysfunction (PGD). Moreover, knowing that a patient has a high risk for the use of ECLS may allow appropriate clinical planning of the procedure with eventual elective ECMO connection.

The investigator's Institution (Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico) is an Italian tertiary referral center for CF and LUTX, as well as for respiratory failure and ECMO support. Aim of this retrospective observational study was 1) to find possible risk factors at the time of enlistment associated with the intraoperative use of ECLS and 2) to compare the outcomes of CF patients treated with ECLS during LUTX or not.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • undergoing LUTX

排除标准

  • single lung transplantation
  • re-transplantation
  • missing medical records.

结局指标

主要结局

Length of mechanical ventilation

时间窗: Jan 2013 Dec 2018

Length of invasive mechanical ventilation (days)

Length of Hospital stay

时间窗: Jan 2013 Dec 2018

Length of hospital stay (days)

Intraoperative use of blood components

时间窗: Jan 2013 Dec 2018

Intraoperative use of: 1) packed red blood cells used (units); 2) fresh frozen plasma (units); 3) pooled platelets (units)

Primary graft dysfunction

时间窗: Jan 2013 Dec 2018

Primary graft dysfunction at 72 hours from re-perfusion of grafts (classes)

Length of intensive care unit (ICU) stay

时间窗: Jan 2013 Dec 2018

Intensive care unit stay (days)

次要结局

  • Survival(Jan 2013 Dec 2018)

研究者

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

Giacomo Grasselli

Chief of Critical Care Unit

Policlinico Hospital

研究点 (1)

Loading locations...

相似试验