Clinical trial NCT03919604: ECMO for Lung Transplantation in Cystic Fibrosis Patients
Official title: Extracorporeal Membrane Oxygenation for Lung Transplantation in Cystic Fibrosis Patients: Predictors and Impact on Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis
lung transplantation
extracorporeal membrane oxygenation
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2019-04-18
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient with CF undergoing LUTX at Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico during the study period

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.

Eligibility criteria: Inclusion Criteria:

* CF
* undergoing LUTX

Exclusion Criteria:

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

Primary outcomes:
measure: Intraoperative use of blood components
timeFrame: Jan 2013 Dec 2018
measure: Length of mechanical ventilation
timeFrame: Jan 2013 Dec 2018
measure: Length of intensive care unit (ICU) stay
timeFrame: Jan 2013 Dec 2018
measure: Length of Hospital stay
timeFrame: Jan 2013 Dec 2018
measure: Primary graft dysfunction
timeFrame: Jan 2013 Dec 2018
Secondary outcomes:
measure: Survival
timeFrame: Jan 2013 Dec 2018
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Ospedale Maggiore Policlinico
Study officials:
affiliation: Universita' di Milano
name: Giacomo Grasselli
role: STUDY_DIRECTOR
References: