Post-Cardiotomy Extra-Corporeal Life Support Study

• Conditions: Resuscitation; Cardiac Surgery; Cardiogenic Shock
• Interventions: Device: Extra-Corporeal Membrane Oxygenation

• Registration Number: NCT03857217
• Lead Sponsor: Maastricht University Medical Center

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.

Study Timeline

• Status Verified: 2019-02
• Study First Submitted: 2019-02-19
• Study First Submitted QC: 2019-02-26
• Last Update Submitted: 2019-02-26
• Study First Posted: 2019-02-27
• Last Update Posted: 2019-02-27
• Study Start: 2019-03
• Primary Completion: 2019-08
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-cardiotomy patients	Extra-Corporeal Membrane Oxygenation	Patients submitted to cardiac surgery

Primary Outcome Measures

Name	Time	Method
In-hospital survival	within 30 days (expected)	to assess the rate of survival
Intra-operative death	within 30 days (expected)	To assess the intra-operative rate of death.
Long-term death	within 1-year	To assess the rate of death at long-term follow-up

Secondary Outcome Measures

Name	Time	Method
Cardiac-related death	during the hospitalization (within 2 months: expected)	Death for cardiac disease
Adverse events	during the hospitalization (within 2 months: expected)	Rethoracotomy for bleeding, Acute Renal Insufficiency, Respiratory insufficiency, Pneumonia, Adult Respiratory Distress Syndrome (ARDS), Postoperative Transient Ischemic Attack (TIA), Postoperative Stroke, Vasoplegic syndrome, Postoperative Right Ventricular Dysfunction, Leg Ischemia, Leg Fasciotomy, Gastro-Intestinal Complications, Laparotomy
Qualify of file	during the hospitalization (within 2 months: expected)	To assess the change in the quality of life after the procedure. The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of the 5 dimensions is divided into 5 levels of perceived problems: Level 1: indicating no problem; Level 2: indicating slight problems; Level 3: indicating moderate problems; Level 4: indicating severe problems; Level 5: indicating extreme problems. Higher scores indicate higher levels of health. An unique health state is defined by combining 1 level from each of the 5 dimensions. A total of 3125 possible health states is defined in this way. Each state is referred to in terms of a 5 digit code. For example state 12345 indicates no problems with mobility, slight problems with washing or dressing, moderate problems with doing usual activities, severe pain or discomfort and extreme anxiety or depression.

Trial Locations

Locations (1)

Maastricht University Medical Centre; 🇳🇱 Maastricht, Netherlands