MedTrace Logo

Cardiac Index-Guided Intraoperative Hemodynamic Management in Pediatric Moyamoya Surgery

NCT07304947 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2025-12-26

No results posted yet for this study

Summary

This prospective randomized controlled trial evaluates whether individualized cardiac index-guided intraoperative hemodynamic management reduces postoperative transient ischemic episodes in pediatric patients undergoing encephaloduroarteriosynangiosis (EDAS) for Moyamoya disease. Patients are randomized 1:1 to goal-directed fluid therapy based on baseline cardiac index versus standard arterial pressure-based management. The primary outcome is the incidence of transient ischemic episodes during hospitalization.

Conditions

  • Moyamoya Disease

Interventions

PROCEDURE

Cardiac Index-Guided Hemodynamic Management

In the experimental arm, intraoperative hemodynamic management is guided by each patient's baseline cardiac index. Cardiac output is continuously monitored using the LiDCO system after arterial line insertion. Baseline cardiac index is calibrated using transthoracic echocardiography, and intraoperative fluids and vasoactive agents are adjusted to maintain cardiac index within ±20% of baseline. Standard anesthesia monitoring is provided to all patients.

PROCEDURE

Blood Pressure-Guided Standard Hemodynamic Management

In the control arm, intraoperative hemodynamic management follows conventional blood pressure-guided practice. After arterial line placement, the LiDCO device remains connected but the display is concealed during anesthesia. Fluids and vasoactive medications are adjusted according to standard MAP-based management. Standard anesthesia monitoring is provided to all patients.

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-02
Primary Completion
2028-12-31
Completion
2029-01-31

Countries

  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07304947 on ClinicalTrials.gov