Actively Recruiting

Phase Not Applicable
Age: 1Month - 18Years
All Genders
ID07304947

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

Age: 1Month - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pediatric patients under 18 years undergoing EDAS surgery for Moyamoya disease under general anesthesia
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

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)

Postoperative Follow-up

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

Loading map...

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

Similar Trials

Impact of Cognitive-Motor Incorporated Training and Brain Ac...

Moyamoya Disease

Actively Recruiting

1 location

The FAME Study: A Family-Based Cohort Study on Moyamoya Dise...

Moyamoya Disease

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here