Clinical trial NCT06986967: Retrograde Versus Antegrade Perfusion in Low-Moderate Hypothermia for Aortic Arch Surgery
Official title: Retrograde Versus Antegrade Perfusion in Low-Moderate Hypothermia for Aortic Arch Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Brain Function
Hemiarch Cardiac Procedure
Keywords: Antegrade Perfusion
Retrograde Perfusion
Brain Perfusion
Circulatory Arrest
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in neurocognitive function as measured by the Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline to 4 weeks
Secondary outcomes:
measure: Effect of Antegrade Perfusion (ACP) vs Retrograde Perfusion (RCP) on brain white matter patency
timeFrame: Baseline, prior to discharge from hospital (up to 7 days), and at 4 weeks
measure: Effect of Antegrade Perfusion (ACP) vs Retrograde Perfusion (RCP) on functional connectivity
timeFrame: Baseline and at 4 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Univeristy
state: North Carolina
Study officials:
affiliation: Duke University
name: Joseph Mathew, M.D.
role: STUDY_CHAIR
References: