ECMO for Lung Transplantation in Cystic Fibrosis Patients

NCT03919604 | Completed

• 1 other identifier: 346_2018bis
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis; lung transplantation; extracorporeal membrane oxygenation

Outcome Measures

Primary Outcomes (5)

• Intraoperative use of blood components

  Intraoperative use of: 1) packed red blood cells used (units); 2) fresh frozen plasma (units); 3) pooled platelets (units)

  Jan 2013 Dec 2018

• Length of mechanical ventilation

  Length of invasive mechanical ventilation (days)

  Jan 2013 Dec 2018

• Length of intensive care unit (ICU) stay

  Intensive care unit stay (days)

  Jan 2013 Dec 2018

• Length of Hospital stay

  Length of hospital stay (days)

  Jan 2013 Dec 2018

• Primary graft dysfunction

  Primary graft dysfunction at 72 hours from re-perfusion of grafts (classes)

  Jan 2013 Dec 2018

Secondary Outcomes (1)

• Survival

  Jan 2013 Dec 2018

Study Arms (2)

ECLS group

Patients with CF undergoing LUTX. Need for intraoperative extracorporeal life support

Procedure: Extracorporeal Life Support

Non-ECLS group

Patients with CF undergoing LUTX. No need for intraoperative extracorporeal life support

Interventions

Extracorporeal Life Support PROCEDURE

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

Also known as: Extracorporeal membrane oxygenation, Cardiopulmonary Bypass

ECLS group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• undergoing LUTX

You may not qualify if:

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

Sponsors & Collaborators

• Policlinico Hospital: lead

Study Sites (1)

Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Extracorporeal Membrane Oxygenation; Cardiopulmonary Bypass

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Giacomo Grasselli

  Universita' di Milano

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Critical Care Unit

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: April 18, 2019
• Study Start: January 1, 2013
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

IT (1)