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Recruiting NCT07304947

Cardiac Index-Guided Intraoperative Hemodynamic Management in Pediatric Moyamoya Surgery

No phase Interventional Moyamoya Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cardiac Index-Guided Hemodynamic Management, Blood Pressure-Guided Standard Hemodynamic Management.
Who it may be relevant to
Registry conditions: Moyamoya Disease. Basic parameters: 1 months — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Primary outcome measures

  • Incidence of transient ischemic episodes during hospitalization [Time frame: Postoperative hospital stay]
Secondary outcome measures (12)
  • MRI-confirmed postoperative cerebral infarction [Time frame: From postoperative Day 0 through Day 7]
  • MRI-confirmed intracranial hemorrhage [Time frame: From postoperative Day 0 through Day 7]
  • Length of hospital stay [Time frame: From postoperative Day 0 through Day 7]
  • Intraoperative fluid volume administered [Time frame: Intraoperative period]
  • Intraoperative vasoactive agent dose [Time frame: Intraoperative period]
  • Intraoperative urine output [Time frame: Intraoperative period]
  • Estimated blood loss [Time frame: Intraoperative period]
  • Duration of anesthesia [Time frame: Intraoperative period]
  • Duration of postoperative mechanical ventilation [Time frame: 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]
  • Percentage of anesthesia time with MAP deviating >20% from baseline [Time frame: Intraoperative period]
  • Percentage of anesthesia time with cardiac index deviating >20% from baseline [Time frame: Intraoperative period]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

South Korea · 1 center
  • Seoul National University Children's Hospital — Seoul

Identifiers

NCT: NCT07304947 · H-2411-122-1591

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗