Type B Aortic Dissection
Conditions
Brief summary
Patients with uncomplicated Type B aortic dissections (TBAD) are traditionally treated in the ICU for impulse control, with BP and HR goals. Local and systemic inflammation often is a resulting consequence of acute aortic dissection. Vagus nerve stimulation can impact hemodynamics and inflammation. This study will utilize a novel transcutaneous auricular vagus nerve stimulator (taVNS) as part of the treatment for patients with TBAD. It's hypothesized that vagus nerve stimulation may provide benefit to the acute TBAD population admitted to ICU by two distinct mechanisms: 1. Through upregulation of parasympathetic pathways which may augment chemical heart rate and blood pressure control through bioelectric stimulation, and 2. downregulation of inflammatory pathways through a neuro-immunological axis.
Interventions
DEVICEAuricular Vagus Nerve Stimulator
Patients will be randomized to treatment with taVNS or placebo. The treatment cohort will undergo transcutaneous auricular vagus nerve stimulation using an in-hose 3D printed earpiece fitted with an off-the-shelf stimulation device (Soterix Medical). Stimulation will occur for 20 minutes, twice daily for 14 days or until discharge, whichever occurs first. The nontreatment cohort (placebo cohort) will have an identical device fitted with planned therapy sessions without any electrical pulses delivered.
DEVICE3D Printed Earpiece
The earpiece will be utilized for both cohorts and fitted with the stimulation device for the treatment group.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults age 18 years and older. 2. Presenting with acute, uncomplicated TBAD 3. Ability to enroll within 24 hours of presentation
Exclusion criteria
1. Prior Aortic Dissections 2. Genetic aortpathies 3. Iatrogenic aortic dissection related to prior procedure(s)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Role of taVNS on serum CRP | Day 1, 3, 7, and 14 should the patient still be admitted. | Identify if taVNS can change serum CRP over 2 weeks in patients with acute type B aortic dissections. |
| Role of taVNS on dissection related end-organ deficits | through study completion, an average of 1 year | Identify if in the acute period (2 weeks) following type B aortic dissections, if taVNS can change the incidence of mesenteric, renal, and limb-related ischemic events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Role of taVNS in mitigation of dissection propagation or evolution | Day 3, Day 30 | Identify if taVNS utilization in the acute period (2 weeks) following type B aortic dissection can lead to a change in aortic dissection propagation based on interval CT imaging (3 days, 1 month) |
| Role of taVNS in surgical intervention rates | Up to 2 weeks | Identify the role of taVNS in surgical intervention rates |
| Role of taVNS in impulse control dosing | Up to 2 weeks | Volume and maximum doses of intravenous impulse control medications, including esmolol and nicardipine, across a period of up to 2 weeks |
| Role of taVNS in ICU and hospital length of stay | Treatment to hospital discharge, expected to occur, on average, between 1-2 weeks from admission/initial treatment | Identify the role of taVNS in ICU and hospital length of stay |
| Role of taVNS in the healthcare economics | Timeframe is defined formally as total hospital length of stay or 2 weeks, whichever is shorter | Correlation between taVNS for Type B aortic dissections and total cost of care in a given hospital admission. Outcome metric is total medical costs associated with the hospital admission (dollars), to be obtained from the hospital registrar and billing services. |
Countries
United States
Contacts
CONTACTMohamed Zayed, MD, PhD, MBA, DFSVS, FAHA, FAC
CONTACTKelly Koogler, RN, BSN
Outcome results
None listed