Clinical trial NCT03857217: Post-Cardiotomy Extra-Corporeal Life Support Study
Official title: Post-Cardiotomy Extra-Corporeal Life Support Study: a Retrospective International Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiogenic Shock
Resuscitation
Cardiac Surgery
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients that require ECLS after cardiac screened for inclusion

Brief summary: Extracorporeal life support is increasingly used after cardiac surgery. Despite improved technology, outcome still remains poor.

This retrospective multicenter cohort study aims to find the (risk) factors associated with the poor prognosis of these patients.

Adult patients who received ECLS after cardiac surgery between 2000 and 2018 are eligible for inclusion

Detailed description: The prevalence of post-cardiotomy extracorporeal life support (PC-ECLS) reported in the literature varies between 0.6% and 3.6% of all cardiac surgical cases and has represented the most frequent indication for ECLS up to 2012.

Indications for PC-ECLS usually include intra-operative failure to wean from cardiopulmonary bypass due to perioperative left, right or biventricular failure, or refractory cardiogenic shock/cardiac arrest in the postoperative period.

Recently, The Extracorporeal Life Support Organization (ELSO) Registry reported a remarkable increase in the use of ECLS as a supportive therapy after cardiac surgery. However a disappointing trend was observed with regards to the in-hospital survival rate, reaching only 15% in the latest period.

Furthermore, despite this increase in use and new technological developments in this area, only a few comprehensive and dedicated reports about PC-ECLS have been presented. Nevertheless, PC-ECLS, has represented the main indication for ECLS utilization, and is characterized by specific aspects (duration and type of underlying disease, severity of comorbidities, indication and type of surgical procedure, modality of access and timing of implant, complication types and rates) when compared to other ECLS indications. Often these aspects are exacerbated when there is limited experience in these procedures, particularly in centers without well-established ECLS programs. All of these factors may potentially influence ECLS management and final outcomes in post-cardiotomy patients, and make this particular setting one in which there are higher risks for unfavorable results. Careful evaluation of patient features, complication rates and management, and in-hospital outcomes according to accumulated experience should provide meaningful information to assess center performance. Furthermore, analysis of overall and trends of outcomes will hopefully indicate further areas of improvement in order to improve the ECLS results. Additionally, a rather small patient cohort within the PC-ELS group, receives veno-venous (VV) support due to post-cardiotomy respiratory failure. While there is only limited data available regarding survival and predictors for a favorable outcome after post-cardiotomy VV-ECMO, these patients will be included in the current trial as well, potentially clarifying additional predictors for survival in this specific patient group. Finally, Extracorporeal carbon-dioxide removal (ECCOR) has as added a new dimension to the intensive care management of acute cardiac and/or respiratory failure in adult patient care. However, regarding post-cardiotomy patients, no studies have been published before. Therefore, as an additional subject, patients receiving ECCOR-support as an ECLS modality after cardiac surgery will be included to the current study as well in order to provide the first post-cardiotomy ECCOR results.

Eligibility criteria: Inclusion Criteria:

* Cardiac surgery prior to Extracorporeal Life Support (ECLS: VA-ECMO, VV-ECMO, ECCOR2) / Extracorporeal Membrane Oxygenation (ECMO);
* Patients who received treatment (cardiac surgery AND adjuvant ECLS) between January 2000 and December 2018

Exclusion Criteria:

* Extra-corporeal life support (ECLS) in patients who had cardiac surgery procedures, but with implant not strictly related to surgery-related hospitalization;
* ECMO implant after discharge will not be considered.

Primary outcomes:
measure: In-hospital survival
timeFrame: within 30 days (expected)
measure: Intra-operative death
timeFrame: within 30 days (expected)
measure: Long-term death
timeFrame: within 1-year
Secondary outcomes:
measure: Adverse events
timeFrame: during the hospitalization (within 2 months: expected)
measure: Cardiac-related death
timeFrame: during the hospitalization (within 2 months: expected)
measure: Qualify of file
timeFrame: during the hospitalization (within 2 months: expected)
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
Study officials:
References:
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