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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.

ECMO for Lung Transplantation in Cystic Fibrosis Patients

Clinicaltrials.gov identifier NCT03919604

Recruitment Status Completed

First Posted April 18, 2019

Last update posted April 18, 2019

Study Description

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.

  • Condition or Disease:Cystic Fibrosis
  • Intervention/Treatment: Procedure: Extracorporeal Life Support
  • Phase: N/A
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.

Study Design
  • Study Type: Observational
  • Actual Enrollment: 80 participants
  • Observational Model: Cohort
  • Time Perspective: Retrospective
  • Official Title: Extracorporeal Membrane Oxygenation for Lung Transplantation in Cystic Fibrosis Patients: Predictors and Impact on Outcome
  • Actual Study Start Date: January 2013
  • Actual Primary Completion Date: December 2018
  • Actual Study Completion Date: December 2018
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: ECLS group
Patients with CF undergoing LUTX. Need for intraoperative extracorporeal life support
Procedure: Extracorporeal Life Support
Any extracorporeal blood treatment technique for respiratory and/or cardiac support
Outcome Measures
  • Primary Outcome Measures: 1. Length of mechanical ventilation [ Time Frame: Jan 2013 Dec 2018 ]
    Length of invasive mechanical ventilation (days)
  • 2. Intraoperative use of blood components [ Time Frame: Jan 2013 Dec 2018 ]
    Intraoperative use of: 1) packed red blood cells used (units); 2) fresh frozen plasma (units); 3) pooled platelets (units)
  • 3. Length of intensive care unit (ICU) stay [ Time Frame: Jan 2013 Dec 2018 ]
    Intensive care unit stay (days)
  • 4. Length of Hospital stay [ Time Frame: Jan 2013 Dec 2018 ]
    Length of hospital stay (days)
  • 5. Primary graft dysfunction [ Time Frame: Jan 2013 Dec 2018 ]
    Primary graft dysfunction at 72 hours from re-perfusion of grafts (classes)
  • Secondary Outcome Measures: 1. Survival [ Time Frame: Jan 2013 Dec 2018 ]
    survival at 31st March 2019.
Eligibility Criteria
  • Ages Eligible for Study: (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • 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
Criteria

Inclusion Criteria:

- CF

- undergoing LUTX

Exclusion Criteria:

- single lung transplantation

- re-transplantation

- missing medical records.

Contacts and Locations
Contacts
Locations

Italy
Ospedale Maggiore Policlinico
Milan

Sponsors and Collaborators

Policlinico Hospital

Investigators

Study Director: Giacomo Grasselli Universita' di Milano

More Information
  • Responsible Party: Policlinico Hospital
  • ClinicalTrials.gov Identifier: NCT03919604 History of Changes
  • Other Study ID Numbers: 346_2018bis
  • First Posted: April 18, 2019 Key Record Dates
  • Last Update Posted: April 18, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Policlinico Hospital: cystic fibrosis
    lung transplantation
    extracorporeal membrane oxygenation
  • Additional relevant MeSH terms: Cystic Fibrosis Fibrosis