Cardiac Index-Guided Intraoperative Hemodynamic Management in Pediatric Moyamoya Surgery

December 11, 2025 updated by: Eun-hee Kim, Seoul National University Hospital

Personalized Cardiac Index-Guided Intraoperative Hemodynamic Management to Improve Postoperative Outcomes in Pediatric Patients With Moyamoya Disease: A Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
94

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • South Korea
      • Seoul, South Korea
        • Recruiting
        • Seoul National University Children's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cardiac index guided hemodynamic management
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.
Active Comparator: Blood pressure guided hemodynamic management
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of transient ischemic episodes during hospitalization
Time Frame: Postoperative hospital stay
From end of surgery through postoperative hospital discharge, up to 7 days
Postoperative hospital stay

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
MRI-confirmed postoperative cerebral infarction
Time Frame: From postoperative Day 0 through Day 7
From postoperative Day 0 through Day 7
MRI-confirmed intracranial hemorrhage
Time Frame: From postoperative Day 0 through Day 7
From postoperative Day 0 through Day 7
Length of hospital stay
Time Frame: From postoperative Day 0 through Day 7
Total number of days from the date of surgery to discharge.
From postoperative Day 0 through Day 7
Intraoperative fluid volume administered
Time Frame: Intraoperative period
Total amount of crystalloid and colloid administered during surgery.
Intraoperative period
Intraoperative vasoactive agent dose
Time Frame: Intraoperative period
Total dose of vasoactive medications administered during anesthesia.
Intraoperative period
Intraoperative urine output
Time Frame: Intraoperative period
Total urine output measured during surgery.
Intraoperative period
Estimated blood loss
Time Frame: Intraoperative period
Total estimated blood loss recorded during the surgical procedure.
Intraoperative period
Duration of anesthesia
Time Frame: Intraoperative period
Time from induction of anesthesia to completion of anesthesia.
Intraoperative period
Duration of postoperative mechanical ventilation
Time Frame: From end of surgery until extubation, assessed up to 24 hours
Total duration of mechanical ventilation following surgery.
From end of surgery until extubation, assessed up to 24 hours
Length of ICU stay
Time Frame: From postoperative Day 0 through ICU discharge, assessed up to 14 days
Number of days spent in the ICU after surgery.
From postoperative Day 0 through ICU discharge, assessed up to 14 days
Percentage of anesthesia time with MAP deviating >20% from baseline
Time Frame: Intraoperative period
Proportion of total anesthesia time during which mean arterial pressure deviates more than 20% from the patient's ward baseline MAP.
Intraoperative period
Percentage of anesthesia time with cardiac index deviating >20% from baseline
Time Frame: Intraoperative period
Proportion of total anesthesia time during which cardiac index deviates more than 20% from the patient's baseline cardiac index measured via preoperative echocardiography.
Intraoperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 2, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-2411-122-1591

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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