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ECMO for Lung Transplantation in Cystic Fibrosis Patients (RetroLUTX)

P

Policlinico Hospital

Status

Completed

Conditions

Cystic Fibrosis

Treatments

Procedure: Extracorporeal Life Support

Study type

Observational

Funder types

Other

Identifiers

NCT03919604
346_2018bis

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • CF
  • undergoing LUTX

Exclusion criteria

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

Trial design

80 participants in 2 patient groups

ECLS group
Description:
Patients with CF undergoing LUTX. Need for intraoperative extracorporeal life support
Treatment:
Procedure: Extracorporeal Life Support
Non-ECLS group
Description:
Patients with CF undergoing LUTX. No need for intraoperative extracorporeal life support

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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