Cardiac index–guided blood flow management during pediatric Moyamoya EDAS surgery
Personalized Cardiac Index-Guided Intraoperative Hemodynamic Management to Improve Postoperative Outcomes in Pediatric Patients With Moyamoya Disease: A Randomized Controlled Trial
This study will test whether using each child's cardiac index to guide fluids and hemodynamic care during EDAS lowers postoperative transient ischemic episodes in children with Moyamoya disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 94 (estimated) |
| Ages | 1 Month to 18 Years |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT07304947 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized 1:1 trial comparing goal-directed intraoperative hemodynamic management guided by baseline cardiac index versus standard blood pressure–based management in children undergoing encephaloduroarteriosynangiosis (EDAS). Children under 18 with Moyamoya disease scheduled for EDAS under general anesthesia are randomized to one of the two management strategies. The intervention arm uses individualized cardiac index targets to direct fluids and vasoactive drugs, while the control arm follows standard arterial pressure targets. The primary outcome is the incidence of transient ischemic episodes during the hospitalization after surgery.
Who should consider this trial
Good fit: Children under 18 years old with Moyamoya disease who are scheduled for EDAS under general anesthesia and meet routine surgical risk criteria are the intended participants.
Not a fit: Patients with high anesthetic risk (ASA 4–5), emergency surgery, known cardiovascular disease, or other conditions judged inappropriate by investigators are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, individualized cardiac index guidance could reduce post‑operative transient ischemic events and related neurologic complications after EDAS in children with Moyamoya.
How similar studies have performed: Goal-directed hemodynamic therapy guided by cardiac output/index has shown benefits in some adult surgical populations, but its application in pediatric Moyamoya surgery is novel and not well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pediatric patients \<18 years undergoing EDAS for Moyamoya disease under general anesthesia Exclusion Criteria: * ASA physical status 4-5 * Emergency surgery * Known cardiovascular disease * Any condition judged inappropriate by investigators
Where this trial is running
Seoul
- Seoul National University Children's Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Jung-Bin Park
- Email: jb4001@snu.ac.kr
- Phone: 820220723664
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.