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NCT Number: NCT07304947

Cardiac Index-Guided Intraoperative Hemodynamic Management in Pediatric Moyamoya Surgery

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.

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Key information

Conditions

Moyamoya Disease Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Central Nervous System Diseases Cerebral Arterial Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Children's Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

Park

CONTACT

[email protected]

8220723664

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac Index-Guided Hemodynamic Management

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 Standard Hemodynamic Management

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.

Primary outcomes

  1. Incidence of transient ischemic episodes during hospitalization

    Time frame: Postoperative hospital stay

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

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

    Time frame: From postoperative Day 0 through Day 7

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

  4. Intraoperative fluid volume administered

    Time frame: Intraoperative period

    Total amount of crystalloid and colloid administered during surgery.

  5. Intraoperative vasoactive agent dose

    Time frame: Intraoperative period

    Total dose of vasoactive medications administered during anesthesia.

  6. Intraoperative urine output

    Time frame: Intraoperative period

    Total urine output measured during surgery.

  7. Estimated blood loss

    Time frame: Intraoperative period

    Total estimated blood loss recorded during the surgical procedure.

  8. Duration of anesthesia

    Time frame: Intraoperative period

    Time from induction of anesthesia to completion of anesthesia.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jung-Bin Park

CONTACT

[email protected]

820220723664

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Dec 26, 2025
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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