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Cardiac Index-Guided Intraoperative Hemodynamic Management in Pediatric Moyamoya Surgery

ConditionMoyamoya Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-18
SponsorSeoul National University Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

ASA physical status 4-5

Emergency surgery

Known cardiovascular disease

Any condition judged inappropriate by investigators

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cardiac Index-Guided Hemodynamic Management

    Procedure/Surgery

    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 Standard Hemodynamic Management

    Procedure/Surgery

    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.

Treatment groups

94 Participants
are divided into 2 treatment groups
Group A: Cardiac index guided hemodynamic managementExperimental treatment 1 intervention
Group B: Blood pressure guided hemodynamic managementActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of transient ischemic episodes during hospitalization

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

Time frame
Postoperative hospital stay

Secondary outcomes

1

MRI-confirmed postoperative cerebral infarction

Time frame
From postoperative Day 0 through Day 7
2

MRI-confirmed intracranial hemorrhage

Time frame
From postoperative Day 0 through Day 7
3

Length of hospital stay

Total number of days from the date of surgery to discharge.

Time frame
From postoperative Day 0 through Day 7
4

Intraoperative fluid volume administered

Total amount of crystalloid and colloid administered during surgery.

Time frame
Intraoperative period

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Hospital

Lead sponsor

Source ClinicalTrials.gov
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