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ECMO for Lung Transplantation in Cystic Fibrosis Patients (RetroLUTX)
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 | Intervention/treatment |
|---|---|
| Cystic Fibrosis | Procedure: Extracorporeal Life Support |
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 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 1, 2013 |
| Actual Primary Completion Date : | December 31, 2018 |
| Actual Study Completion Date : | December 31, 2018 |
| Group/Cohort | 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
Other Names:
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Non-ECLS group
Patients with CF undergoing LUTX. No need for intraoperative extracorporeal life support
|
- 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)
- Length of mechanical ventilation [ Time Frame: Jan 2013 Dec 2018 ]Length of invasive mechanical ventilation (days)
- Length of intensive care unit (ICU) stay [ Time Frame: Jan 2013 Dec 2018 ]Intensive care unit stay (days)
- Length of Hospital stay [ Time Frame: Jan 2013 Dec 2018 ]Length of hospital stay (days)
- Primary graft dysfunction [ Time Frame: Jan 2013 Dec 2018 ]Primary graft dysfunction at 72 hours from re-perfusion of grafts (classes)
- Survival [ Time Frame: Jan 2013 Dec 2018 ]survival at 31st March 2019.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- CF
- undergoing LUTX
Exclusion Criteria:
- single lung transplantation
- re-transplantation
- missing medical records.
| Italy | |
| Ospedale Maggiore Policlinico | |
| Milan, Italy, 20122 | |
| Study Director: | Giacomo Grasselli | Universita' di Milano |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | April 11, 2019 | ||||
| First Posted Date | April 18, 2019 | ||||
| Last Update Posted Date | April 18, 2019 | ||||
| Actual Study Start Date | January 1, 2013 | ||||
| Actual Primary Completion Date | December 31, 2018 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
Survival [ Time Frame: Jan 2013 Dec 2018 ] survival at 31st March 2019.
|
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | 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 | ||||
| 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. |
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| 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. |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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 | ||||
| Condition | Cystic Fibrosis | ||||
| Intervention | Procedure: Extracorporeal Life Support
Any extracorporeal blood treatment technique for respiratory and/or cardiac support
Other Names:
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
80 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | December 31, 2018 | ||||
| Actual Primary Completion Date | December 31, 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Italy | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03919604 | ||||
| Other Study ID Numbers | 346_2018bis | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Giacomo Grasselli, Policlinico Hospital | ||||
| Study Sponsor | Policlinico Hospital | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Policlinico Hospital | ||||
| Verification Date | April 2019 | ||||
