IABP with VA ECMO for Cardiogenic Shock

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Utah

Disqualifiers: Metastatic cancer, Atrial septostomy, Pregnancy, others

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 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.

Will I have to stop taking my current medications?

The trial information 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 data supports the effectiveness of the treatment Intra-aortic Balloon Pump (IABP) with VA ECMO for Cardiogenic Shock?

Research suggests that using an intra-aortic balloon pump (IABP) along with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) may reduce in-hospital deaths in patients with cardiogenic shock compared to using VA-ECMO alone. A study found that patients receiving both treatments had a lower death rate (58.4%) compared to those with only VA-ECMO (63.1%).

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Is the combination of IABP and VA-ECMO generally safe for humans?

The safety of using an intra-aortic balloon pump (IABP) with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) for cardiogenic shock is not fully clear, as studies show mixed results. While IABP may help improve heart function, the risks and benefits in real-life settings have not been thoroughly evaluated.

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How does the treatment of IABP with VA ECMO for cardiogenic shock differ from other treatments?

This treatment combines two technologies: the intra-aortic balloon pump (IABP), which helps the heart pump more effectively, and veno-arterial extracorporeal membrane oxygenation (VA-ECMO), which provides heart and lung support. This combination is unique because it aims to improve blood flow and reduce the heart's workload simultaneously, which is not typically achieved with standard treatments.

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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.

Inclusion Criteria

I am 18 years old or older.

I have been diagnosed with acute heart failure.

My heart condition is worsening despite medical treatment.

Exclusion Criteria

My cancer has spread to other parts of my body.

Planned LV unloading on ECMO

Anticipated death <72 hours

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive VA ECMO with or without LV unloading, with measurements taken via lab work, echocardiography, and pulmonary artery catheter

Up to 6 months

Daily monitoring during ECMO, regular follow-ups until ICU discharge

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of myocardial recovery and mortality

Up to 6 months

Regular follow-ups until hospital discharge

Participant Groups

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.

Group I: With LV Unloading Experimental Treatment 1 Intervention

Patients on VA ECMO who randomize to receive LV unloading

Group II: Without LV Unloading Active Control 1 Intervention

Patients on VA ECMO who randomize to receive no LV unloading

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Utah Salt Lake City, UT

Who Is Running the Clinical Trial?

University of Utah Lead Sponsor

University of Minnesota Collaborator

References

1. United States pubmed.ncbi.nlm.nih.gov

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.

2. England pubmed.ncbi.nlm.nih.gov

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).

3. England pubmed.ncbi.nlm.nih.gov

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.

4. Germany pubmed.ncbi.nlm.nih.gov

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.

5. Germany pubmed.ncbi.nlm.nih.gov

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

6. Ireland pubmed.ncbi.nlm.nih.gov

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.

7. United States pubmed.ncbi.nlm.nih.gov

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.

8. England pubmed.ncbi.nlm.nih.gov

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.