Cardiac Surgery Clinical Trial
Official title:
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
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05054179 -
Pecto-Intercostal Fascial Plane Block Catheter Trial for Reduction of Sternal Pain
|
Phase 2/Phase 3 | |
| Completed |
NCT04051021 -
Non-Pharmacological Interventions on Patient Experience and Healthcare Utilization in Adult Cardiac Surgery Patients
|
N/A | |
| Recruiting |
NCT04604886 -
The Consistency of Cardiac Output Measured by Pulmonary Artery Catheter and LiDCO in Cardiac Surgical Patients
|
N/A | |
| Recruiting |
NCT04075981 -
Prevention Atrial Fibrillation by BOTulinum Toxin Injections (BOTAF)
|
Phase 3 | |
| Completed |
NCT04062396 -
Comparison of Remowell 2 and Inspire on Delirium and Cognitive Dysfunction
|
N/A | |
| Recruiting |
NCT04709705 -
DMSO Cryopreserved Platelets in Cardiopulmonary Bypass Surgery (CRYPTICS)
|
Phase 2/Phase 3 | |
| Not yet recruiting |
NCT05563662 -
SURgical Registry of ENDocarditis EuRope
|
||
| Withdrawn |
NCT03289104 -
Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX
|
N/A | |
| Completed |
NCT02964026 -
Study of Clinical Outcomes Associated With the Pulmonary Artery Catheter (PAC) in Cardiac Surgery Patients
|
N/A | |
| Completed |
NCT04199039 -
Effects of Endotracheal Tube Fixation Methods on Hemodynamic Parameters During Endotracheal Suction
|
N/A | |
| Completed |
NCT03563196 -
Diagnosis Of Pulmonary Complications After Cardiac Surgery In Children
|
||
| Completed |
NCT02471001 -
The Levels of Anaesthetics in Heart Muscle During Heart Surgery
|
N/A | |
| Completed |
NCT02325726 -
RRI Compared With NephroCheckTM to Predict Acute Renal Failure After Cardiac Surgery.
|
N/A | |
| Completed |
NCT01246947 -
Tricuspid Annuloplasty for Moderate Tricuspid Regurgitation Associated With Miral Operation
|
N/A | |
| Completed |
NCT01151254 -
Comparison of Propofol Based Versus Volatile Based Anesthesia and Postoperative Sedation
|
N/A | |
| Completed |
NCT00821262 -
Sevoflurane in Cardiac Surgery
|
Phase 4 | |
| Completed |
NCT00996099 -
Continuous Glucose Monitoring Combined With Computer Algorithm for Intensive Insulin Therapy in Cardiosurgical Patients
|
N/A | |
| Completed |
NCT00617955 -
Effects of Aprotinin During Cardiac Surgery/Long Term Death Rates
|
N/A | |
| Completed |
NCT00336466 -
The Erythropoietin NeuroProtective Effect: Assessment in CABG Surgery (TENPEAKS)
|
Phase 2 | |
| Completed |
NCT00337805 -
Double Blind Randomized Trial of Saline vs Pentaspan for Resuscitation After Cardiac Surgery
|
Phase 2/Phase 3 |