Post-Cardiotomy Extra-Corporeal Life Support Study
PELS
1 other identifier
observational
2,000
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2019
CompletedFirst Posted
Study publicly available on registry
February 27, 2019
CompletedStudy Start
First participant enrolled
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedFebruary 27, 2019
February 1, 2019
5 months
February 19, 2019
February 26, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
In-hospital survival
to assess the rate of survival
within 30 days (expected)
Intra-operative death
To assess the intra-operative rate of death.
within 30 days (expected)
Long-term death
To assess the rate of death at long-term follow-up
within 1-year
Secondary Outcomes (3)
Adverse events
during the hospitalization (within 2 months: expected)
Cardiac-related death
during the hospitalization (within 2 months: expected)
Qualify of file
during the hospitalization (within 2 months: expected)
Study Arms (1)
Post-cardiotomy patients
Patients submitted to cardiac surgery
Interventions
ECMO is implanted in cardiac surgery patients.
Eligibility Criteria
All patients that require ECLS after cardiac screened for inclusion
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maastricht University Medical Centre
Maastricht, Netherlands
Related Publications (12)
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.
PMID: 20599396RESULTRastan 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.
PMID: 20106393RESULTWhitman 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.
PMID: 27666787RESULTSaxena 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.
PMID: 25865760RESULTFukuhara 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.
PMID: 26874519RESULTSauer 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.
PMID: 25303799RESULTMcCarthy 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.
PMID: 26686427RESULTSong 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.
PMID: 27499972RESULTNakamura 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.
PMID: 23436039RESULTShekar 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.
PMID: 25032748RESULTBunge 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.
PMID: 38856631DERIVEDMariani 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.
PMID: 37421269DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2019
First Posted
February 27, 2019
Study Start
March 1, 2019
Primary Completion
August 1, 2019
Study Completion
September 1, 2019
Last Updated
February 27, 2019
Record last verified: 2019-02