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Cardiac Index-Guided Intraoperative Hemodynamic Management in Pediatric Moyamoya Surgery

NCT ID: NCT07304947

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-02

Study Completion Date

2029-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Moyamoya Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Cardiac index guided hemodynamic management

Group Type EXPERIMENTAL

Cardiac Index-Guided Hemodynamic Management

Intervention Type PROCEDURE

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.

Blood pressure guided hemodynamic management

Group Type ACTIVE_COMPARATOR

Blood Pressure-Guided Standard Hemodynamic Management

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Eun-hee Kim

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Children's Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jung-Bin Park

Role: CONTACT

Phone: 820220723664

Email: [email protected]

Facility Contacts

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Park

Role: primary

Other Identifiers

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H-2411-122-1591

Identifier Type: -

Identifier Source: org_study_id