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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

94

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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)

December 2, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

January 31, 2029

Study Registration Dates

First Submitted

November 28, 2025

First Submitted That Met QC Criteria

December 11, 2025

First Posted (Actual)

December 26, 2025

Study Record Updates

Last Update Posted (Actual)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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