ECMO for Lung Transplantation in Cystic Fibrosis Patients
- Conditions
- Cystic Fibrosis
- Interventions
- Procedure: Extracorporeal Life Support
- Registration Number
- NCT03919604
- Lead Sponsor
- Policlinico Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- CF
- undergoing LUTX
- single lung transplantation
- re-transplantation
- missing medical records.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ECLS group Extracorporeal Life Support Patients with CF undergoing LUTX. Need for intraoperative extracorporeal life support
- Primary Outcome Measures
Name Time Method Length of mechanical ventilation Jan 2013 Dec 2018 Length of invasive mechanical ventilation (days)
Length of Hospital stay Jan 2013 Dec 2018 Length of hospital stay (days)
Intraoperative use of blood components 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 Jan 2013 Dec 2018 Primary graft dysfunction at 72 hours from re-perfusion of grafts (classes)
Length of intensive care unit (ICU) stay Jan 2013 Dec 2018 Intensive care unit stay (days)
- Secondary Outcome Measures
Name Time Method Survival Jan 2013 Dec 2018 survival at 31st March 2019.
Trial Locations
- Locations (1)
Ospedale Maggiore Policlinico
🇮🇹Milan, Italy