Post-Cardiotomy Extra-Corporeal Life Support Study (PELS)

February 26, 2019 updated by: Maastricht University Medical Center

Post-Cardiotomy Extra-Corporeal Life Support Study: a Retrospective International Multicenter Cohort Study

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands
        • Maastricht University Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients that require ECLS after cardiac screened for inclusion

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Post-cardiotomy patients
Patients submitted to cardiac surgery
Device: Extra-Corporeal Membrane Oxygenation
ECMO is implanted in cardiac surgery patients.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 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
during the hospitalization (within 2 months: expected)
Cardiac-related death
Time Frame: during the hospitalization (within 2 months: expected)
Death for cardiac disease
during the hospitalization (within 2 months: expected)
Qualify of file
Time Frame: 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.
during the hospitalization (within 2 months: expected)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2019

Primary Completion (Anticipated)

August 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

February 19, 2019

First Submitted That Met QC Criteria

February 26, 2019

First Posted (Actual)

February 27, 2019

Study Record Updates

Last Update Posted (Actual)

February 27, 2019

Last Update Submitted That Met QC Criteria

February 26, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL69209.068.19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiac Surgery

Clinical Trials on Extra-Corporeal Membrane Oxygenation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe