Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06336655
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-03-08
Brief Title:
Physiology of Unloading VA ECMO Trial
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Physiology of Unloading VA ECMO Trial
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
Although extracorporeal membrane oxygenation ECMO for cardiogenic shock CS is used in over 3000 patients per year the best management strategies are not known Identifying and improving treatment of CS is critically important as CS occurs in 160000 patients per year in the US with a 50 mortality rate VA ECMO is an increasingly used method of mechanical circulatory support MCS for patients with CS refractory to medical therapy Despite the benefit of full cardiopulmonary support ECMO is also thought to increase after load in the failing heart- which paradoxically reduces cardiac output and may lead to myocardial injury and cardiac congestion A potential solution is to add a device to VA ECMO that decreases after-load - known as left ventricular LV unloading LV unloading can be achieved with different approaches directly with transvalvular pumps known as a peripheral ventricular assist device pVAD or indirectly with an intra-aortic balloon pump IABP
Preliminary data suggests that unloading the LV is associated with improved survival Results from a cohort of VA ECMO patients with medical CS showed a hospital survival benefit LV unloading aOR 087 079 094 p0001 Data has also shown that the survival benefit of LV unloading was much larger with pVAD HR 06 but with higher complications including limb ischemia - a potentially catastrophic complication However results also show that different unloading approaches have different physiologic effects on the myocardium and on peripheral perfusion - highlighting the uncomfortable observation that it is not known how physiologically these unloading devices lead to changes in survival
There are two potential pathways whereby LV unloading could influence survival including myocardial effects distension injury ejection fraction and peripheral effects peripheral pulse pressure lactate clearance CO2 gap Determining the physiologic effects from LV unloading according to device type and patient etiology will allow us to match the intervention with the patients physiology Data suggests that ECMO patients with acute myocardial infarction AMI have different mortality and different physiologic changes than patients with decompensated chronic heart failure CHF when unloaded
The ultimate goal is to reduce morbidity and mortality in cardiogenic shock This study will define the physiologic benefit of LV unloading during CS
Preliminary data suggests that unloading the LV is associated with improved survival Results from a cohort of VA ECMO patients with medical CS showed a hospital survival benefit LV unloading aOR 087 079 094 p0001 Data has also shown that the survival benefit of LV unloading was much larger with pVAD HR 06 but with higher complications including limb ischemia - a potentially catastrophic complication However results also show that different unloading approaches have different physiologic effects on the myocardium and on peripheral perfusion - highlighting the uncomfortable observation that it is not known how physiologically these unloading devices lead to changes in survival
There are two potential pathways whereby LV unloading could influence survival including myocardial effects distension injury ejection fraction and peripheral effects peripheral pulse pressure lactate clearance CO2 gap Determining the physiologic effects from LV unloading according to device type and patient etiology will allow us to match the intervention with the patients physiology Data suggests that ECMO patients with acute myocardial infarction AMI have different mortality and different physiologic changes than patients with decompensated chronic heart failure CHF when unloaded
The ultimate goal is to reduce morbidity and mortality in cardiogenic shock This study will define the physiologic benefit of LV unloading during CS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None