Brain Function, Hemiarch Cardiac Procedure
Conditions
Keywords
Antegrade Perfusion, Retrograde Perfusion, Brain Perfusion, Circulatory Arrest
Brief summary
The purpose of this study is to compare brain function after surgical circulatory arrest using either antegrade perfusion or retrograde perfusion.
Detailed description
The purpose of this study is to compare brain function after surgical circulatory arrest (surgeon stops the heart-lung machine to work on the heart) in antegrade perfusion versus retrograde perfusion. There are 2 ways to supply blood to the brain, antegrade and retrograde perfusion. In antegrade perfusion, the surgeon accesses one of two arteries that branch off from the aorta (the artery that delivers blood to the rest of the body) to provide blood to the brain. In retrograde perfusion, the surgeon accesses the superior vena cava (large vein bringing blood back to the heart) to supply blood to the brain. It is standard practice to cool the patient down during this type of surgery to help protect the brain. Despite measures to safeguard brain health, some patients still experience postoperative cognitive decline such as confusion, delirium and agitation. The investigators are conducting this study to see which method of perfusing the brain is superior and decreases the symptoms of confusion, delirium and agitation.
Interventions
PROCEDUREAntegrade Perfusion
Procedure in which the surgeon accesses one of two arteries that branch off from the aorta to provide blood to the brain.
PROCEDURERetrograde Perfusion
Procedure in which the surgeon accesses the superior vena cava to supply blood to the brain.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The neuroimaging personnel will be blinded to the assignment of the subject.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. \> 18 years of age 2. Participant's that are scheduled for elective proximal aortic reconstructive surgery (ascending aorta + aortic valve or root) with concomitant proximal hemi-arch replacement via median sternotomy
Exclusion criteria
1. \< 18 years of age 2. history of symptomatic cerebrovascular disease, e.g., prior stroke with residual deficit 3. current alcoholism (\> 2 drinks/day) 4. current psychiatric illness requiring pharmacotherapy 5. current drug abuse (any illicit drug use in the past 3 months) 6. hepatic insufficiency (liver function tests \> 1.5 times the upper limit of normal) 7. severe pulmonary insufficiency (requiring home oxygen therapy) 8. renal failure (serum creatinine \> 2.0 mg/dL) 9. claustrophobic fear 10. unable to read and thus unable to complete the cognitive testing 11. pregnant women 12. patients who score \<19 om the Montreal Cognitive Assessment (MoCA) or ≥27 on the baseline Center for Epidemiological Studies Depression (CES-D) scale 13. patients who have pre-existing unsafe implants for 3 Tesla magnetic resonance imaging (MRI) 14. Patients who have received chemotherapy in the last 12 months or radiation to the brain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in neurocognitive function as measured by the Montreal Cognitive Assessment (MoCA) | Baseline to 4 weeks | The MoCA is a brief screening tool used to assess cognitive function. It consists of 30 tasks covering various cognitive domains, including attention, memory, visuospatial abilities, and executive function. The total score ranges from 0 to 30, where a higher score indicates better cognitive function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Antegrade Perfusion (ACP) vs Retrograde Perfusion (RCP) on brain white matter patency | Baseline, prior to discharge from hospital (up to 7 days), and at 4 weeks | Measured by MRI at baseline, prior to discharge, and at 4 weeks. |
| Effect of Antegrade Perfusion (ACP) vs Retrograde Perfusion (RCP) on functional connectivity | Baseline and at 4 weeks | Measured by MRI at baseline and at 4 weeks. |
Countries
United States
Contacts
CONTACTKelly Rodden, BSN
CONTACTBonita Hilliard, RPM
STUDY_CHAIRJoseph Mathew, M.D.
Duke University
Outcome results
None listed