Actively Recruiting
Personalized Cardiac Index-Guided Intraoperative Hemodynamic Management to Improve Postoperative Outcomes in Pediatric Patients With Moyamoya Disease: A Randomized Controlled Trial
Led by Seoul National University Hospital · Updated on 2025-12-26
94
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether a personalized cardiac index-guided approach to managing blood flow during surgery can reduce postoperative transient ischemic episodes in children undergoing encephaloduroarteriosynangiosis (EDAS) surgery for Moyamoya disease. This prospective randomized controlled trial compares this approach to the standard method of managing blood pressure during surgery. The study focuses on pediatric patients under general anesthesia and aims to improve postoperative outcomes. Participants are randomly assigned to one of two groups: one group receives intraoperative hemodynamic management guided by their baseline cardiac index, which is continuously monitored and adjusted to stay within 20% of their baseline using the LiDCO system and echocardiography. The other group receives standard blood pressure-guided management where fluids and medications are adjusted based on mean arterial pressure. Both groups receive standard anesthesia monitoring during surgery. Throughout their hospital stay, participants will be closely monitored for transient ischemic episodes and other complications using MRI scans, fluid and medication tracking, and assessments of anesthesia and ventilation duration. Researchers will measure outcomes such as postoperative cerebral infarction, intracranial hemorrhage, length of hospital and ICU stay, intraoperative blood loss, and deviations from baseline cardiac index and blood pressure. The study follow-up includes the postoperative hospital stay and up to 14 days in the ICU, allowing comprehensive evaluation of recovery and safety.
CONDITIONS
Brief Title
Cardiac Index-Guided Intraoperative Hemodynamic Management in Pediatric Moyamoya Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pediatric patients under 18 years undergoing EDAS surgery for Moyamoya disease under general anesthesia
You will not qualify if you...
- ASA physical status 4 or 5
- Emergency surgery
- Known cardiovascular disease
- Any condition judged inappropriate by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Intraoperative period
Participants undergo EDAS surgery for Moyamoya disease under general anesthesia with intraoperative hemodynamic management guided either by cardiac index or blood pressure.
1 visit (in-person, day of surgery)
Duration - From end of surgery through up to 14 days
Participants are monitored in the hospital for postoperative outcomes including transient ischemic episodes, cerebral infarction, intracranial hemorrhage, mechanical ventilation duration, and ICU stay.
Daily visits during hospital stay up to 14 days
Trial Site Locations
Total: 1 location
1
Seoul National University Children's Hospital
Seoul, South Korea
Actively Recruiting
Research Team
J
Jung-Bin Park
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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