Cardiogenic ShockNCT05658276
Establishing Physiologic Outcomes for Ventricular Unloading on VA ECMO
An observational study of Cardiogenic Shock, run by University of Utah at 2 sites in 2 countries.
Trial summary
Aim 1: Prospective, observational analysis of the association between echocardiographic measures of cardiac function and left ventricular unloading on VA ECMO. Aim 2: Prospective, observational analysis of the association between clinical laboratory biomarkers and left ventricular unloading on VA ECMO. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Dec 2023to 1 Mar 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to our facility in cardiogenic shock.
Who may be able to join
- Patients who are 18 years of age or older
- Patients with cardiogenic shock
- Patients with mechanical circulatory support, specifically veno-arterial extracorporeal membrane oxygenation (VA ECMO) inserted peripherally
Who cannot join
- None
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Aim 1: Prospective, observational analysis of the association between echocardiographic measures of cardiac function and left ventricular unloading on VA ECMO.
Aim 2: Prospective, observational analysis of the association between clinical laboratory biomarkers and left ventricular unloading on VA ECMO.
Read the detailed description
Mechanical circulatory support (MCS) is increasingly utilized as a means of hemodynamic support among cardiogenic shock (CS) patients refractory to optimal medical management. MCS modalities include using either an intra-aortic balloon pump (IABP), Impella®, or ECMO, each with unique benefit/harm profiles. Among the various MCS devices, extracorporeal membrane oxygenation (ECMO) is described as the highest level of support, capable of providing 5+ liters per minute of oxygenated blood flow but is the most invasive. Despite the benefit of maximal cardiopulmonary support, ECMO increases afterload in a failing heart. Left ventricular (LV) unloading or decompression (using simultaneous IABP or Impella®) has been suggested as potential improvement. Observational studies suggest a benefit with LV unloading during VA ECMO for CS, but the mechanisms underlying the association are poorly understood. Prior to trials, a mechanistic understanding of the effect of different LV unloading strategies on key physiologic abnormalities in CS is needed, as the physiologic effects of LV unloading during VA ECMO for CS remain insufficiently defined.
The objective of this study is to define serial changes in common clinical variables routinely obtained during management of patients in CS. These clinical variables are readily accessible to clinicians, but are not typically collected in a sufficiently granular serial manner to characterize their utility as clinical biomarkers. By obtaining scheduled assessments, repeated in a prospective cohort over the clinical course of CS, the investigators will define the physiologic effects of different LV unloading strategies in cardiogenic shock. We will examine a) echocardiographic measures of ventricular distension, and b) blood biochemical measures of peripheral perfusion.
- Conditions
- Cardiogenic Shock
- Keywords
- Mechanical circulatory support
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| With LV Unloading | Adults (18+) who are in cardiogenic shock and being treated with mechanical circulatory support (veno-arterial ECMO) inserted peripherally. The patients in this group will also have an additional device, such as an Impella or an intra-aortic balloon pump (IABP) for left ventricular unloading. The decision whether or not to unload the patient will be purely clinical. Data will be collected from the patient's chart and entered into a secure database. A standard complete transthoracic echocardiogram will be completed at enrollment and then again 7 days from enrollment (+/- 2 days). Additional blood tests will be ordered for the 7 days after enrollment. All tests will be ordered on Day 1 (patient on ECMO, prior to any LV unloading) and additionally as follows: * Troponin: Daily for 7 days * NT-proBNP: Daily for 7 days * PCO2 gap (in blood gas analysis): Every 6 hours for 3 days * Lactate (in blood gas analysis): Every 12 hours for 3 days * cBIN1: Twice in 7 days | |
| Without LV Unloading | Adults (18+) who are in cardiogenic shock and being treated with mechanical circulatory support (veno-arterial ECMO) inserted peripherally. The patients in this group will not have any LV unloading device in addition to the ECMO support. The decision not to do LV unloading will be purely clinical. Data will be collected from the patient's chart and entered into a secure database. A standard complete transthoracic echocardiogram will be completed at enrollment and then again 7 days from enrollment (+/- 2 days). Additional blood tests will be ordered for the 7 days after enrollment. All tests will be ordered on Day 1 (patient on ECMO, prior to any LV unloading) and additionally as follows: * Troponin: Daily for 7 days * NT-proBNP: Daily for 7 days * PCO2 gap (in blood gas analysis): Every 6 hours for 3 days * Lactate (in blood gas analysis): Every 12 hours for 3 days * cBIN1: Twice in 7 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular function (ejection fraction)
Ejection fraction will be measured via echocardiogram and compared between time points and between groups
Measured: Day 1/Enrollment
Left ventricular function (ejection fraction)
Ejection fraction will be measured via echocardiogram and compared between time points and between groups
Measured: After LV unloading (within the first week of ECMO treatment; no specific day as this is a clinical decision)
Left ventricular function (ejection fraction)
Ejection fraction will be measured via echocardiogram and compared between time points and between groups
Measured: Day 5
Secondary outcomes (8)
Distension
Left ventricular end-diastolic dysfunction (LVEDD) will be measured via echocardiogram and compared between groups and between time points.
Measured: Day 1/Enrollment
Distension
Left ventricular end-diastolic dysfunction (LVEDD) will be measured via echocardiogram and compared between groups and between time points.
Measured: After LV unloading (within the first week of ECMO treatment; no specific day as this is a clinical decision)
Distension
Left ventricular end-diastolic dysfunction (LVEDD) will be measured via echocardiogram and compared between groups and between time points.
Measured: Day 5
Peripheral perfusion per lactate
Measurements of lactate will indicate differences in peripheral perfusion between time points and between groups
Measured: Daily (days 1-7)
Peripheral perfusion per CO2 gap
Measurements of carbon dioxide (CO2) gap will indicate differences in peripheral perfusion between time points and between groups
Measured: Daily (days 1-7)
Cardiac injury per troponin
Measurements of troponin will indicate levels of cardiac injury between time points and between groups.
Measured: Daily (days 1-7)
Cardiac injury per BNP
Measurements of B-type natriuretic peptide (BNP) will indicate levels of cardiac injury between time points and between groups.
Measured: Daily (days 1-7)
Cardiac injury per cBIN1
Measurements of cardiac BIN1 (cBIN1) will indicate levels of cardiac injury between time points and between groups.
Measured: Twice in 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start15 Dec 2023
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Why it stopped: Did not enroll, prioritizing randomized trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Tonna, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658276
- Sponsor's protocol ID
- 142543
- Status last verified
- Mar 2024
- First submitted
- 31 Oct 2022
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided at this time.
Publications
Tonna J, Selzman C, Bartos J, Presson A, Jo Y, Becker LB, Youngquist ST, Thiagarajan RR, Johnson A, Rycus P, Keenan H. Abstract 117: Critical Care Management, Hospital Case Volume, and Survival After Extracorporeal Cardiopulmonary Resuscitation. Circulation. 2020 2020/11/17;142(Suppl_4):A117-A117. doi: 10.1161/circ.142.suppl_4.117.
Rao P, Khalpey Z, Smith R, Burkhoff D, Kociol RD. Venoarterial Extracorporeal Membrane Oxygenation for Cardiogenic Shock and Cardiac Arrest. Circ Heart Fail. 2018 Sep;11(9):e004905. doi: 10.1161/CIRCHEARTFAILURE.118.004905.
PubMed 30354364Hitzeman TC, Xie Y, Zadikany RH, Nikolova AP, Baum R, Caldaruse AM, Agvanian S, Melmed GY, McGovern DPB, Geft DR, Chang DH, Moriguchi JD, Hage A, Azarbal B, Czer LS, Kittleson MM, Patel JK, Wu AHB, Kobashigawa JA, Hamilton M, Hong T, Shaw RM. cBIN1 Score (CS) Identifies Ambulatory HFrEF Patients and Predicts Cardiovascular Events. Front Physiol. 2020 May 25;11:503. doi: 10.3389/fphys.2020.00503. eCollection 2020.
PubMed 32670075Nikolova AP, Hitzeman TC, Baum R, Caldaruse AM, Agvanian S, Xie Y, Geft DR, Chang DH, Moriguchi JD, Hage A, Azarbal B, Czer LS, Kittleson MM, Patel JK, Wu AHB, Kobashigawa JA, Hamilton M, Hong T, Shaw RM. Association of a Novel Diagnostic Biomarker, the Plasma Cardiac Bridging Integrator 1 Score, With Heart Failure With Preserved Ejection Fraction and Cardiovascular Hospitalization. JAMA Cardiol. 2018 Dec 1;3(12):1206-1210. doi: 10.1001/jamacardio.2018.3539.
PubMed 30383171Eckman PM, Katz JN, El Banayosy A, Bohula EA, Sun B, van Diepen S. Veno-Arterial Extracorporeal Membrane Oxygenation for Cardiogenic Shock: An Introduction for the Busy Clinician. Circulation. 2019 Dec 10;140(24):2019-2037. doi: 10.1161/CIRCULATIONAHA.119.034512. Epub 2019 Dec 9.
PubMed 31815538Combes A, Price S, Slutsky AS, Brodie D. Temporary circulatory support for cardiogenic shock. Lancet. 2020 Jul 18;396(10245):199-212. doi: 10.1016/S0140-6736(20)31047-3.
PubMed 32682486Kim D, Jang WJ, Park TK, Cho YH, Choi JO, Jeon ES, Yang JH. Echocardiographic Predictors of Successful Extracorporeal Membrane Oxygenation Weaning After Refractory Cardiogenic Shock. J Am Soc Echocardiogr. 2021 Apr;34(4):414-422.e4. doi: 10.1016/j.echo.2020.12.002. Epub 2020 Dec 13.
PubMed 33321165Aissaoui N, Luyt CE, Leprince P, Trouillet JL, Leger P, Pavie A, Diebold B, Chastre J, Combes A. Predictors of successful extracorporeal membrane oxygenation (ECMO) weaning after assistance for refractory cardiogenic shock. Intensive Care Med. 2011 Nov;37(11):1738-45. doi: 10.1007/s00134-011-2358-2. Epub 2011 Oct 1.
PubMed 21965097
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Physiologic Outcomes for Ventricular Unloading on VA ECMO
- ClinicalTrials.gov ID
- NCT05658276
- Acronym / sponsor ID
- 142543
- Conditions
- Cardiogenic Shock
- Keywords
- Mechanical circulatory support
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Did not enroll, prioritizing randomized trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 20 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim 1: Prospective, observational analysis of the association between echocardiographic measures of cardiac function and left ventricular unloading on VA ECMO.
Aim 2: Prospective, observational analysis of the association between clinical laboratory biomarkers and left ventricular unloading on VA ECMO.
Detailed description
Mechanical circulatory support (MCS) is increasingly utilized as a means of hemodynamic support among cardiogenic shock (CS) patients refractory to optimal medical management. MCS modalities include using either an intra-aortic balloon pump (IABP), Impella®, or ECMO, each with unique benefit/harm profiles. Among the various MCS devices, extracorporeal membrane oxygenation (ECMO) is described as the highest level of support, capable of providing 5+ liters per minute of oxygenated blood flow but is the most invasive. Despite the benefit of maximal cardiopulmonary support, ECMO increases afterload in a failing heart. Left ventricular (LV) unloading or decompression (using simultaneous IABP or Impella®) has been suggested as potential improvement. Observational studies suggest a benefit with LV unloading during VA ECMO for CS, but the mechanisms underlying the association are poorly understood. Prior to trials, a mechanistic understanding of the effect of different LV unloading strategies on key physiologic abnormalities in CS is needed, as the physiologic effects of LV unloading during VA ECMO for CS remain insufficiently defined.
The objective of this study is to define serial changes in common clinical variables routinely obtained during management of patients in CS. These clinical variables are readily accessible to clinicians, but are not typically collected in a sufficiently granular serial manner to characterize their utility as clinical biomarkers. By obtaining scheduled assessments, repeated in a prospective cohort over the clinical course of CS, the investigators will define the physiologic effects of different LV unloading strategies in cardiogenic shock. We will examine a) echocardiographic measures of ventricular distension, and b) blood biochemical measures of peripheral perfusion.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With LV Unloading | – | –Adults (18+) who are in cardiogenic shock and being treated with mechanical circulatory support (veno-arterial ECMO) inserted peripherally. The patients in this group will also have an additional device, such as an Impella or an intra-aortic balloon pump (IABP) for left ventricular unloading. The decision whether or not to unload the patient will be purely clinical. Data will be collected from the patient's chart and entered into a secure database. A standard complete transthoracic echocardiogram will be completed at enrollment and then again 7 days from enrollment (+/- 2 days). Additional blood tests will be ordered for the 7 days after enrollment. All tests will be ordered on Day 1 (patient on ECMO, prior to any LV unloading) and additionally as follows: * Troponin: Daily for 7 days * NT-proBNP: Daily for 7 days * PCO2 gap (in blood gas analysis): Every 6 hours for 3 days * Lactate (in blood gas analysis): Every 12 hours for 3 days * cBIN1: Twice in 7 days |
| Without LV Unloading | – | –Adults (18+) who are in cardiogenic shock and being treated with mechanical circulatory support (veno-arterial ECMO) inserted peripherally. The patients in this group will not have any LV unloading device in addition to the ECMO support. The decision not to do LV unloading will be purely clinical. Data will be collected from the patient's chart and entered into a secure database. A standard complete transthoracic echocardiogram will be completed at enrollment and then again 7 days from enrollment (+/- 2 days). Additional blood tests will be ordered for the 7 days after enrollment. All tests will be ordered on Day 1 (patient on ECMO, prior to any LV unloading) and additionally as follows: * Troponin: Daily for 7 days * NT-proBNP: Daily for 7 days * PCO2 gap (in blood gas analysis): Every 6 hours for 3 days * Lactate (in blood gas analysis): Every 12 hours for 3 days * cBIN1: Twice in 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to our facility in cardiogenic shock.
Key inclusion criteria (3 listed)
- Patients who are 18 years of age or older
- Patients with cardiogenic shock
- Patients with mechanical circulatory support, specifically veno-arterial extracorporeal membrane oxygenation (VA ECMO) inserted peripherally
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Left ventricular function (ejection fraction)
Time frame: Day 1/Enrollment
Ejection fraction will be measured via echocardiogram and compared between time points and between groups
Left ventricular function (ejection fraction)
Time frame: After LV unloading (within the first week of ECMO treatment; no specific day as this is a clinical decision)
Ejection fraction will be measured via echocardiogram and compared between time points and between groups
Left ventricular function (ejection fraction)
Time frame: Day 5
Ejection fraction will be measured via echocardiogram and compared between time points and between groups
8 secondary outcomes
Distension
Time frame: Day 1/Enrollment
Distension
Time frame: After LV unloading (within the first week of ECMO treatment; no specific day as this is a clinical decision)
Distension
Time frame: Day 5
Peripheral perfusion per lactate
Time frame: Daily (days 1-7)
Peripheral perfusion per CO2 gap
Time frame: Daily (days 1-7)
Cardiac injury per troponin
Time frame: Daily (days 1-7)
Cardiac injury per BNP
Time frame: Daily (days 1-7)
Cardiac injury per cBIN1
Time frame: Twice in 7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- BackgroundTonna J, Selzman C, Bartos J, Presson A, Jo Y, Becker LB, Youngquist ST, Thiagarajan RR, Johnson A, Rycus P, Keenan H. Abstract 117: Critical Care Management, Hospital Case Volume, and Survival After Extracorporeal Cardiopulmonary Resuscitation. Circulation. 2020 2020/11/17;142(Suppl_4):A117-A117. doi: 10.1161/circ.142.suppl_4.117.
- Background: PubMed 30354364Rao P, Khalpey Z, Smith R, Burkhoff D, Kociol RD. Venoarterial Extracorporeal Membrane Oxygenation for Cardiogenic Shock and Cardiac Arrest. Circ Heart Fail. 2018 Sep;11(9):e004905. doi: 10.1161/CIRCHEARTFAILURE.118.004905.
- Background: PubMed 32670075Hitzeman TC, Xie Y, Zadikany RH, Nikolova AP, Baum R, Caldaruse AM, Agvanian S, Melmed GY, McGovern DPB, Geft DR, Chang DH, Moriguchi JD, Hage A, Azarbal B, Czer LS, Kittleson MM, Patel JK, Wu AHB, Kobashigawa JA, Hamilton M, Hong T, Shaw RM. cBIN1 Score (CS) Identifies Ambulatory HFrEF Patients and Predicts Cardiovascular Events. Front Physiol. 2020 May 25;11:503. doi: 10.3389/fphys.2020.00503. eCollection 2020.
- Background: PubMed 30383171Nikolova AP, Hitzeman TC, Baum R, Caldaruse AM, Agvanian S, Xie Y, Geft DR, Chang DH, Moriguchi JD, Hage A, Azarbal B, Czer LS, Kittleson MM, Patel JK, Wu AHB, Kobashigawa JA, Hamilton M, Hong T, Shaw RM. Association of a Novel Diagnostic Biomarker, the Plasma Cardiac Bridging Integrator 1 Score, With Heart Failure With Preserved Ejection Fraction and Cardiovascular Hospitalization. JAMA Cardiol. 2018 Dec 1;3(12):1206-1210. doi: 10.1001/jamacardio.2018.3539.
- Background: PubMed 31815538Eckman PM, Katz JN, El Banayosy A, Bohula EA, Sun B, van Diepen S. Veno-Arterial Extracorporeal Membrane Oxygenation for Cardiogenic Shock: An Introduction for the Busy Clinician. Circulation. 2019 Dec 10;140(24):2019-2037. doi: 10.1161/CIRCULATIONAHA.119.034512. Epub 2019 Dec 9.
- Background: PubMed 32682486Combes A, Price S, Slutsky AS, Brodie D. Temporary circulatory support for cardiogenic shock. Lancet. 2020 Jul 18;396(10245):199-212. doi: 10.1016/S0140-6736(20)31047-3.
- Background: PubMed 33321165Kim D, Jang WJ, Park TK, Cho YH, Choi JO, Jeon ES, Yang JH. Echocardiographic Predictors of Successful Extracorporeal Membrane Oxygenation Weaning After Refractory Cardiogenic Shock. J Am Soc Echocardiogr. 2021 Apr;34(4):414-422.e4. doi: 10.1016/j.echo.2020.12.002. Epub 2020 Dec 13.
- Background: PubMed 21965097Aissaoui N, Luyt CE, Leprince P, Trouillet JL, Leger P, Pavie A, Diebold B, Chastre J, Combes A. Predictors of successful extracorporeal membrane oxygenation (ECMO) weaning after assistance for refractory cardiogenic shock. Intensive Care Med. 2011 Nov;37(11):1738-45. doi: 10.1007/s00134-011-2358-2. Epub 2011 Oct 1.
- Individual participant dataSharing planned: Undecided. Undecided at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiogenic Shock, run by University of Utah at 2 sites in 2 countries.
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 3 inclusion and 1 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: withdrawn, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular function (ejection fraction) (time frame: Day 1/Enrollment). 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 NCT05658276, which also lists 8 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 12 Nov 2024.