Post-Cardiotomy Extra-Corporeal Life Support Study

NCT ID: NCT03857217

Last Updated: 2019-02-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-31
• Study Completion Date: 2019-09-30

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.

Conditions

Cardiogenic Shock; Resuscitation; Cardiac Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Post-cardiotomy patients

Patients submitted to cardiac surgery

Extra-Corporeal Membrane Oxygenation

Intervention Type: DEVICE

ECMO is implanted in cardiac surgery patients.

Interventions

Extra-Corporeal Membrane Oxygenation

ECMO is implanted in cardiac surgery patients.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Maastricht University Medical Centre

Maastricht, , Netherlands

Countries

Netherlands

Facility Contacts

Lorusso Roberto, MD, PhD

Role: primary

roberto.lorussobs@gmail.com

0031433877095

Berta Ganizada, MSc

Role: backup

berta.ganizada@mumc.nl

0031617377191

References

Elsharkawy HA, Li L, Esa WA, Sessler DI, Bashour CA. Outcome in patients who require venoarterial extracorporeal membrane oxygenation support after cardiac surgery. J Cardiothorac Vasc Anesth. 2010 Dec;24(6):946-51. doi: 10.1053/j.jvca.2010.03.020.

Reference Type: RESULT

PMID: 20599396 (View on PubMed)

Rastan AJ, Dege A, Mohr M, Doll N, Falk V, Walther T, Mohr FW. Early and late outcomes of 517 consecutive adult patients treated with extracorporeal membrane oxygenation for refractory postcardiotomy cardiogenic shock. J Thorac Cardiovasc Surg. 2010 Feb;139(2):302-11, 311.e1. doi: 10.1016/j.jtcvs.2009.10.043.

Reference Type: RESULT

PMID: 20106393 (View on PubMed)

Whitman GJ. Extracorporeal membrane oxygenation for the treatment of postcardiotomy shock. J Thorac Cardiovasc Surg. 2017 Jan;153(1):95-101. doi: 10.1016/j.jtcvs.2016.08.024. Epub 2016 Aug 31.

Reference Type: RESULT

PMID: 27666787 (View on PubMed)

Saxena P, Neal J, Joyce LD, Greason KL, Schaff HV, Guru P, Shi WY, Burkhart H, Li Z, Oliver WC, Pike RB, Haile DT, Schears GJ. Extracorporeal Membrane Oxygenation Support in Postcardiotomy Elderly Patients: The Mayo Clinic Experience. Ann Thorac Surg. 2015 Jun;99(6):2053-60. doi: 10.1016/j.athoracsur.2014.11.075. Epub 2015 Apr 10.

Reference Type: RESULT

PMID: 25865760 (View on PubMed)

Fukuhara S, Takeda K, Garan AR, Kurlansky P, Hastie J, Naka Y, Takayama H. Contemporary mechanical circulatory support therapy for postcardiotomy shock. Gen Thorac Cardiovasc Surg. 2016 Apr;64(4):183-91. doi: 10.1007/s11748-016-0625-4. Epub 2016 Feb 13.

Reference Type: RESULT

PMID: 26874519 (View on PubMed)

Sauer CM, Yuh DD, Bonde P. Extracorporeal membrane oxygenation use has increased by 433% in adults in the United States from 2006 to 2011. ASAIO J. 2015 Jan-Feb;61(1):31-6. doi: 10.1097/MAT.0000000000000160.

Reference Type: RESULT

PMID: 25303799 (View on PubMed)

McCarthy FH, McDermott KM, Kini V, Gutsche JT, Wald JW, Xie D, Szeto WY, Bermudez CA, Atluri P, Acker MA, Desai ND. Trends in U.S. Extracorporeal Membrane Oxygenation Use and Outcomes: 2002-2012. Semin Thorac Cardiovasc Surg. 2015 Summer;27(2):81-8. doi: 10.1053/j.semtcvs.2015.07.005. Epub 2015 Jul 22.

Reference Type: RESULT

PMID: 26686427 (View on PubMed)

Song JH, Woo WK, Song SH, Kim HH, Kim BJ, Kim HE, Kim do J, Suh JW, Shin YR, Park HK, Lee SH, Joo HC, Lee S, Chang BC, Yoo KJ, Kim YS, Youn YN. Outcome of veno-venous extracorporeal membrane oxygenation use in acute respiratory distress syndrome after cardiac surgery with cardiopulmonary bypass. J Thorac Dis. 2016 Jul;8(7):1804-13. doi: 10.21037/jtd.2016.05.86.

Reference Type: RESULT

PMID: 27499972 (View on PubMed)

Nakamura H, Yamaguchi H, Amano A, Nakao T. Venovenous extracorporeal membrane oxygenation is effective against post-cardiotomy acute respiratory failure in adults. Gen Thorac Cardiovasc Surg. 2013 Jul;61(7):402-8. doi: 10.1007/s11748-013-0226-4. Epub 2013 Feb 24.

Reference Type: RESULT

PMID: 23436039 (View on PubMed)

Shekar K, Mullany DV, Thomson B, Ziegenfuss M, Platts DG, Fraser JF. Extracorporeal life support devices and strategies for management of acute cardiorespiratory failure in adult patients: a comprehensive review. Crit Care. 2014 May 9;18(3):219. doi: 10.1186/cc13865.

Reference Type: RESULT

PMID: 25032748 (View on PubMed)

Bunge JJH, Mariani S, Meuwese C, van Bussel BCT, Di Mauro M, Wiedeman D, Saeed D, Pozzi M, Loforte A, Boeken U, Samalavicius R, Bounader K, Hou X, Buscher H, Salazar L, Meyns B, Herr D, Matteucci S, Sponga S, MacLaren G, Russo C, Formica F, Sakiyalak P, Fiore A, Camboni D, Raffa GM, Diaz R, Wang IW, Jung JS, Belohlavek J, Pellegrino V, Bianchi G, Pettinari M, Barbone A, Garcia JP, Shekar K, Whitman GJR, Gommers D, Dos Reis Miranda D, Lorusso R; Post-Cardiotomy Extracorporeal Life Support (PELS-1) Investigators. Characteristics and Outcomes of Prolonged Venoarterial Extracorporeal Membrane Oxygenation After Cardiac Surgery: The Post-Cardiotomy Extracorporeal Life Support (PELS-1) Cohort Study. Crit Care Med. 2024 Oct 1;52(10):e490-e502. doi: 10.1097/CCM.0000000000006349. Epub 2024 Jun 7.

Reference Type: DERIVED

PMID: 38856631 (View on PubMed)

Mariani S, Heuts S, van Bussel BCT, Di Mauro M, Wiedemann D, Saeed D, Pozzi M, Loforte A, Boeken U, Samalavicius R, Bounader K, Hou X, Bunge JJH, Buscher H, Salazar L, Meyns B, Herr D, Matteucci MLS, Sponga S, MacLaren G, Russo C, Formica F, Sakiyalak P, Fiore A, Camboni D, Raffa GM, Diaz R, Wang IW, Jung JS, Belohlavek J, Pellegrino V, Bianchi G, Pettinari M, Barbone A, Garcia JP, Shekar K, Whitman GJR, Lorusso R; PELS-1 Investigators *. Patient and Management Variables Associated With Survival After Postcardiotomy Extracorporeal Membrane Oxygenation in Adults: The PELS-1 Multicenter Cohort Study. J Am Heart Assoc. 2023 Jul 18;12(14):e029609. doi: 10.1161/JAHA.123.029609. Epub 2023 Jul 8.

Reference Type: DERIVED

PMID: 37421269 (View on PubMed)

Other Identifiers

NL69209.068.19

Identifier Type: -

Identifier Source: org_study_id