IABP with VA ECMO for Cardiogenic Shock
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Utah
No Placebo Group
Prior Safety Data
Approved in 4 jurisdictions
Trial Summary
What is the purpose of this trial?The goal of this clinical trial is to compare the use of veno-arterial extracorporeal membrane oxygenation (VA ECMO) with and without left ventricular (LV) unloading in patients being treated for non-postoperative cardiogenic shock (CS). The main aims of the study are:
1. To determine the physiologic effects on cardiopulmonary congestion of adding LV unloading to VA ECMO
2. To determine the effects on myocardial function of adding LV unloading to ECMO
3. To test the effects on myocardial recovery of adding LV unloading to VA ECMO
Participants who are being treated with VA ECMO will be randomized to receive or not receive LV unloading in the form of an intra-aortic balloon pump (IABP). Over the course of the study, the investigators will obtain measurements via lab work, echocardiography, and pulmonary artery catheter that will allow comparison of the two groups.
Is the treatment IABP with VA ECMO a promising treatment for cardiogenic shock?The treatment IABP with VA ECMO for cardiogenic shock shows mixed results. Some studies suggest it might help improve heart function and recovery, but the overall benefits are still unclear.24578
Do I have to stop taking my current medications for the trial?The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What safety data exists for using IABP with VA-ECMO in cardiogenic shock?The safety and effectiveness of using IABP with VA-ECMO in cardiogenic shock have been studied with mixed results. Some studies suggest potential benefits in improving cardiac function and survival, while others find inconclusive evidence. A systematic review and meta-analysis indicate that the benefit of this combination in postcardiotomy cardiogenic shock is not clear. Additionally, the European Society of Cardiology downgraded the use of IABP in 2012, reflecting ongoing debate about its efficacy and safety.12467
What data supports the idea that IABP with VA ECMO for Cardiogenic Shock is an effective treatment?The available research shows that using an intra-aortic balloon pump (IABP) along with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) for cardiogenic shock can lead to better outcomes compared to using VA-ECMO alone. Specifically, a systematic review and meta-analysis found that patients treated with both IABP and VA-ECMO had a lower rate of in-hospital deaths (58.4%) compared to those treated with VA-ECMO alone (63.1%). This suggests that the combination of IABP with VA-ECMO may improve survival rates for patients with cardiogenic shock.23457
Eligibility Criteria
This trial is for patients with non-postoperative cardiogenic shock, a severe heart condition where the heart can't pump enough blood. Participants must be receiving veno-arterial extracorporeal membrane oxygenation (VA ECMO) treatment.Treatment Details
The study compares two approaches: one group receives VA ECMO alone, while the other gets VA ECMO plus left ventricular unloading using an intra-aortic balloon pump (IABP). The effects on heart and lung function will be measured through lab tests, echocardiography, and pulmonary artery catheter data.
2Treatment groups
Experimental Treatment
Active Control
Group I: With LV UnloadingExperimental Treatment1 Intervention
Patients on VA ECMO who randomize to receive LV unloading
Group II: Without LV UnloadingActive Control1 Intervention
Patients on VA ECMO who randomize to receive no LV unloading
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of UtahSalt Lake City, UT
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Who is running the clinical trial?
University of UtahLead Sponsor
University of MinnesotaCollaborator
References
Intra-aortic balloon counterpulsation in the emergency department: a 7-year review and analysis of predictors of survival. [2019]Intra-aortic balloon pump (IABP) counterpulsation in cardiogenic shock (CS) is suggested as bridging therapy to definite emergency revascularization, heart transplantation and acute valvular repair. Data concerning the use of IABP counterpulsation in an emergency department (ED) are rare.
Extracorporeal life support for cardiogenic shock: influence of concomitant intra-aortic balloon counterpulsation. [2014]Intra-aortic balloon counterpulsation (IABP) during extracorporeal life support (ECLS) for cardiogenic shock may improve pulsatility and coronary perfusion, thereby promoting recovery of cardiac function. However, the risks and benefits of IABP during ECLS in real clinical settings have not been evaluated. This study aims to evaluate the effect of IABP on the early outcome of ECLS for cardiogenic shock.
Effect of an intra-aortic balloon pump with venoarterial extracorporeal membrane oxygenation on mortality of patients with cardiogenic shock: a systematic review and meta-analysis†. [2020]An intra-aortic balloon pump (IABP) concomitant with venoarterial extracorporeal membrane oxygenation (VA-ECMO) is frequently used to support patients with refractory cardiogenic shock (CS). Because of the lack of evidence of the adjunctive benefit, the goal of the study was to compare the effect of VA-ECMO plus IABP with that of VA-ECMO alone. Systematic searches were conducted to identify studies using PubMed, Embase, the Cochrane Library and the International Clinical Trials Registry Platform. Studies reporting on patients with adult CS treated with VA-ECMO plus IABP or VA-ECMO alone were identified and included. The primary outcome was in-hospital death. The secondary outcomes included neurological, gastrointestinal and limb-related complications. The study protocol was registered at PROSPERO (CRD42017069259). A total of 29 studies comprising 4576 patients were included. The pooled in-hospital deaths of patients on VA-ECMO were 1441/2285 (63.1%) compared with 1339/2291 (58.4%) for patients with adjunctive IABP. VA-ECMO plus IABP was associated with decreased in-hospital deaths [risk ratio (RR) 0.90; 95% confidence interval (CI) 0.85-0.95; P
Concomitant Intra-Aortic Balloon Pump Use in Cardiogenic Shock Requiring Veno-Arterial Extracorporeal Membrane Oxygenation. [2022]There are contrasting reports on the effectiveness of a concomitant intra-aortic balloon pump (IABP) in cardiogenic shock patients treated with veno-arterial extracorporeal membrane oxygenation (VA-ECMO). This study sought to compare short-term mortality in patients with cardiogenic shock treated with VA-ECMO with and without IABP.
Left ventricular decompression on Veno-arterial extracorporeal membrane oxygenation with intra-aortic balloon Counterpulsation. [2020]Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) has been used increasingly to support patients with cardiogenic shock (CS). There has been growing recognition of the favorable and unfavorable hemodynamic effects of this therapy and recent interest in the use of other percutaneous circulatory support devices to offset some of the potentially harmful hemodynamic effects. Herein, we provide visual evidence of the effects of intra-aortic balloon pump (IABP) counterpulsation for a patient with peripheral VA-ECMO cannulation.
Impact of the Change in ESC Guidelines on Clinical Characteristics and Outcomes of Cardiogenic Shock Patients Receiving IABP Therapy. [2020]Intra-aortic balloon pump (IABP) counterpulsation provides mechanical support for patients with cardiogenic shock. The aim of the study is to evaluate the clinical characteristics and outcomes of patients with cardiogenic shock receiving IABP before and after the European Society of Cardiology (ESC) downgraded the use of IABP from a class I to a class IIb in 2012.
Venoarterial extracorporeal membrane oxygenation with intra-aortic balloon pump for postcardiotomy cardiogenic shock: A systematic review and meta-analysis. [2023]Intra-aortic balloon pump (IABP) is currently recommended as a strategy to address the increased afterload in patients who received venoarterial extracorporeal membrane oxygenation (VA-ECMO). The benefit of VA-ECMO with IABP in postcardiotomy cardiogenic shock is inconclusive. A systematic review and meta-analysis was conducted to assess the influence of VA-ECMO with IABP for postcardiotomy cardiogenic shock (PCS).
Effect of intra-aortic balloon pump with veno-arterial extracorporeal membrane oxygenation in acute myocardial infarction with cardiogenic shock: A meta-analysis. [2023]The effectiveness of a concomitant intra-aortic balloon pump (IABP) with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) intervention in acute myocardial infarction with cardiogenic shock (AMICS) patients is contested in the literature. This study sought to compare short-term mortality weaning rate from VA-ECMOin AMICS cases.