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Cardiogenic ShockPELSNCT03857217

Post-Cardiotomy Extra-Corporeal Life Support Study

An observational study of Cardiogenic Shock and Resuscitation, run by Maastricht University Medical Center at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Cardiogenic Shock, Resuscitation, Cardiac Surgery
What is being tested?
Extra-Corporeal Membrane Oxygenation
Type of treatment
Medical device
How many people
2,000 participants
Where
1 siteNetherlands
Study dates
Mar 2019to Sep 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients that require ECLS after cardiac screened for inclusion

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Maastricht University Medical Centre

    Maastricht

    Lorusso Roberto, MD, PhD, 0031433877095, roberto.lorussobs@gmail.com

    Berta Ganizada, MSc, 0031617377191, berta.ganizada@mumc.nl

Other trials in Netherlands

About this study

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

Read the 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.

Being tested
Extra-Corporeal Membrane Oxygenation
Medical subject headings
Shock, Cardiogenic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Extra-Corporeal Membrane OxygenationDevice

    ECMO is implanted in cardiac surgery patients.

Study groups in NCT03857217
Study groupRoleWhat they receive
Post-cardiotomy patientsPatients submitted to cardiac surgery
Receives: Device: Extra-Corporeal Membrane Oxygenation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In-hospital survival

    to assess the rate of survival

    Measured: within 30 days (expected)

  2. Intra-operative death

    To assess the intra-operative rate of death.

    Measured: within 30 days (expected)

  3. Long-term death

    To assess the rate of death at long-term follow-up

    Measured: within 1-year

Secondary outcomes (3)

  1. Adverse events

    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

    Measured: during the hospitalization (within 2 months: expected)

  2. Cardiac-related death

    Death for cardiac disease

    Measured: during the hospitalization (within 2 months: expected)

  3. Qualify of file

    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.

    Measured: during the hospitalization (within 2 months: expected)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2019
  2. Study startMar 2019 (estimated)
  3. Primary completionAug 2019 (estimated)
  4. Study completionSep 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03857217
Sponsor's protocol ID
NL69209.068.19
Acronym
PELS
Status last verified
Feb 2019
First submitted
19 Feb 2019
Last updated
27 Feb 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 20599396

  • 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.

    PubMed 20106393

  • 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.

    PubMed 27666787

  • 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.

    PubMed 25865760

  • 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.

    PubMed 26874519

  • 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.

    PubMed 25303799

  • 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.

    PubMed 26686427

  • 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.

    PubMed 27499972

  • 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.

    PubMed 23436039

  • 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.

    PubMed 25032748

  • Bari G, Mariani S, van Bussel BCT, Di Mauro M, Conci L, Saeed D, Pozzi M, Loforte A, Boeken U, Samalavicius R, Bounader K, Hou X, Bunge JJH, Buscher H, Salazar L, Meyns B, Mazzeffi M, Matteucci S, Sponga S, Sorokin V, Russo C, Formica F, Sakiyalak P, Fiore A, Camboni D, Maria Raffa G, Diaz R, Wang IW, Jung JS, Belohlavek J, Pellegrino V, Bianchi G, Pettinari M, Barbone A, Garcia JP, Shekar K, Whitman G, Lorusso R; PELS Investigators. Post-Cardiotomy Extracorporeal Life Support Following Aortic Surgery. ASAIO J. 2026 Oct 1;72(10):e306-e314. doi: 10.1097/MAT.0000000000002619. Epub 2025 Dec 17.

    PubMed 41406462

  • 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.

    PubMed 38856631

  • Mariani S, Ravaux JM, van Bussel BCT, De Piero ME, van Kruijk SMJ, Schaefer AK, Wiedemann D, Saeed D, Pozzi M, Loforte A, Boeken U, Samalavicius R, Bounader K, Hou X, Bunge JJH, Buscher H, Salazar L, Meyns B, Mazzeffi MA, Matteucci S, Sponga S, Sorokin V, 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 Investigators. Features and outcomes of female and male patients requiring postcardiotomy extracorporeal life support. J Thorac Cardiovasc Surg. 2024 Dec;168(6):1701-1711.e30. doi: 10.1016/j.jtcvs.2024.04.033. Epub 2024 May 17.

    PubMed 38762034

  • 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.

    PubMed 37421269

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiogenic Shock and Resuscitation, run by Maastricht University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-hospital survival (time frame: within 30 days (expected)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03857217, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.

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Post-Cardiotomy Extra-Corporeal Life Support Study | AzTrials