NCT07304947

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
34mo left

Started Dec 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Dec 2025Jan 2029

First Submitted

Initial submission to the registry

November 28, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

December 2, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 26, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2029

Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

3.1 years

First QC Date

November 28, 2025

Last Update Submit

December 11, 2025

Conditions

Moyamoya Disease

Outcome Measures

Primary Outcomes (1)

  • Incidence of transient ischemic episodes during hospitalization

    From end of surgery through postoperative hospital discharge, up to 7 days

    Postoperative hospital stay

Secondary Outcomes (12)

  • MRI-confirmed postoperative cerebral infarction

    From postoperative Day 0 through Day 7

  • MRI-confirmed intracranial hemorrhage

    From postoperative Day 0 through Day 7

  • Length of hospital stay

    From postoperative Day 0 through Day 7

  • Intraoperative fluid volume administered

    Intraoperative period

  • Intraoperative vasoactive agent dose

    Intraoperative period

  • +7 more secondary outcomes

Study Arms (2)

Cardiac index guided hemodynamic management

EXPERIMENTAL
Procedure: Cardiac Index-Guided Hemodynamic Management

Blood pressure guided hemodynamic management

ACTIVE COMPARATOR
Procedure: Blood Pressure-Guided Standard Hemodynamic Management

Interventions

Cardiac Index-Guided Hemodynamic ManagementPROCEDURE

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.

Cardiac index guided hemodynamic management
Blood Pressure-Guided Standard Hemodynamic ManagementPROCEDURE

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.

Blood pressure guided hemodynamic management

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Pediatric patients \<18 years undergoing EDAS for Moyamoya disease under general anesthesia

You may not qualify if:

  • ASA physical status 4-5
  • Emergency surgery
  • Known cardiovascular disease
  • Any condition judged inappropriate by investigators

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Children's Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Moyamoya Disease

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCerebral Arterial DiseasesIntracranial Arterial DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Jung-Bin Park

CONTACT

820220723664jb4001@snu.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

November 28, 2025

First Posted

December 26, 2025

Study Start

December 2, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

January 31, 2029

Last Updated

December 26, 2025

Record last verified: 2025-12

Locations

KR(1)