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Completed

NCT Number: NCT03919604

ECMO for Lung Transplantation in Cystic Fibrosis Patients

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale Maggiore Policlinico

Milan, 20122, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • CF
  • undergoing LUTX

Exclusion criteria

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

Treatment and study plan

extracorporeal life support

Procedure

Any extracorporeal blood treatment technique for respiratory and/or cardiac support

Other names: Extracorporeal membrane oxygenation, Cardiopulmonary Bypass

Primary outcomes

  1. 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)

  2. Length of mechanical ventilation

    Time frame: Jan 2013 Dec 2018

    Length of invasive mechanical ventilation (days)

  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 outcomes

  1. Survival

    Time frame: Jan 2013 Dec 2018

    survival at 31st March 2019.

Sponsors and collaborators

Lead sponsor

Policlinico Hospital

Other

Registry information

Official study title

Extracorporeal Membrane Oxygenation for Lung Transplantation in Cystic Fibrosis Patients: Predictors and Impact on Outcome

Acronym: RetroLUTX

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Apr 18, 2019
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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