Extracorporeal Membrane Oxygenation, Extracorporeal Membrane Oxygenation Complication
Conditions
Keywords
Extracorporeal life support, Extracorporeal membrane oxygenation
Brief summary
Extracorporeal life support (ECLS) is used as a last resort intervention in patients with severe cardiac, circulatory and/or respiratory failure with high (\>80%) expected mortality. Despite considerable improvements in patient selection and outcomes, mortality and morbidity after ECLS remain high. An improved selection and management of patients who are supported with ECLS is therefore unquestionably needed from a perspective of optimal patient care and the socio-economic impact of this costly intervention.
Detailed description
This observational multicenter study was designed to serve the following objectives: 1. Develop a (dynamic) prediction tool for survival and quality of life outcomes 1 year after ECLS support for the situation at baseline and 7 days after ECLS initiation 2. Study the association between application of left ventricular unloading and ECLS support duration and weanability 3. Description of the incidence of VA ECLS weaning failure and identification of predictors for VA ECLS weaning failure Under this umbrella research protocol, the data collected by this observational multicenter study can also be reused for potential novel substudies with the objective to improve the quality of care and the efficiency of current treatment strategies involving ECLS.
Interventions
None listed
Sponsors
Leiden University Medical Center
Erasmus Medical Center
St. Antonius Hospital
Catharina Ziekenhuis Eindhoven
Isala
UMC Utrecht
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Having received (VA and/or VV) ECLS * All ECLS indications (refractory cardiac, circulatory and/or respiratory failure) * Surgical and medical patients
Exclusion criteria
* \< 18 years of age * ECLS confined to cardiac surgery in the operating room (OR) or in the catheterization laboratory * Objection against use of clinical data (opt-out principle)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QoL | 1 year after admission | By the EuroQol EQ-5D, an instrument to measure health related quality of life. It assesses health in five domains; mobility, self-care, usual activities, pain/discomfort and anxiety/depression, ranging from 1 to 3 in each domain (e.g. from 1 'I am not anxious or depressed' to 3 'I am extremely anxious or depressed' in the anxiety/depression domain) finding 243 unique health states. These health states can be converted into an index ranging from 0 (death) to 1 (perfect health) |
| Mortality | In-hospital mortality up to 30 days and through study completion, an average of 1 year. | — |
| Weaning success | In-hospital up to 30 days | 30 day survival without left ventricular assist device, heart transplantation or short Term mechanical support |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30 day mortality | 30 days | — |
| Complications | During ECLS support up to 30 days and 1 year | Incidence of complications (infection, thrombosis, bleeding, respiratory and cardiovascular complications, mechanical complications, neurological complications) |
| 60 day mortality | 60 days | — |
| ECLS support duration | ECLS days up to 30 days and 1 year | Total duration (in days) of ECLS support |
| ICU admission length of stay | ICU days up to 30 days and 1 year | Length of stay (in days) of ICU admission |
Countries
Netherlands
Contacts
Primary ContactLara CA Pladet, MSc
Backup ContactDirk W Donker, Professor
Outcome results
None listed