ECMO for Lung Transplantation in Cystic Fibrosis Patients
NCT ID: NCT03919604
Last Updated: 2019-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
80 participants
OBSERVATIONAL
2013-01-01
2018-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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ECLS group
Patients with CF undergoing LUTX. Need for intraoperative extracorporeal life support
Extracorporeal Life Support
Any extracorporeal blood treatment technique for respiratory and/or cardiac support
Non-ECLS group
Patients with CF undergoing LUTX. No need for intraoperative extracorporeal life support
No interventions assigned to this group
Interventions
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Extracorporeal Life Support
Any extracorporeal blood treatment technique for respiratory and/or cardiac support
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* undergoing LUTX
Exclusion Criteria
* re-transplantation
* missing medical records.
ALL
No
Sponsors
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Policlinico Hospital
OTHER
Responsible Party
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Giacomo Grasselli
Chief of Critical Care Unit
Principal Investigators
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Giacomo Grasselli
Role: STUDY_DIRECTOR
Universita' di Milano
Locations
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Ospedale Maggiore Policlinico
Milan, , Italy
Countries
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Other Identifiers
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346_2018bis
Identifier Type: -
Identifier Source: org_study_id
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