Moyamoya DiseaseNCT07304947
Cardiac Index-Guided Intraoperative Hemodynamic Management in Pediatric Moyamoya Surgery
A study testing Cardiac Index-Guided Hemodynamic Management and Blood Pressure-Guided Standard Hemodynamic Management in people with Moyamoya Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Moyamoya Disease
- What is being tested?
- Cardiac Index-Guided Hemodynamic Management and Blood Pressure-Guided Standard Hemodynamic Management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Dec 2025to 31 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients <18 years undergoing EDAS for Moyamoya disease under general anesthesia
Who cannot join
- ASA physical status 4-5
- Emergency surgery
- Known cardiovascular disease
- Any condition judged inappropriate by investigators
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Children's Hospital
Seoul
Park, 8220723664, jb4001@snu.ac.kr
About this study
Official title: 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.
- Conditions
- Moyamoya Disease
- Being tested
- Cardiac Index-Guided Hemodynamic Management, Blood Pressure-Guided Standard Hemodynamic Management
- Medical subject headings
- Moyamoya Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Index-Guided Hemodynamic ManagementProcedure or 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 ManagementProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac index guided hemodynamic management | Experimental | Not described Receives: Procedure: Cardiac Index-Guided Hemodynamic Management |
| Blood pressure guided hemodynamic management | Active comparator | Not described Receives: Procedure: Blood Pressure-Guided Standard Hemodynamic Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of transient ischemic episodes during hospitalization
From end of surgery through postoperative hospital discharge, up to 7 days
Measured: Postoperative hospital stay
Secondary outcomes (12)
MRI-confirmed postoperative cerebral infarction
Measured: From postoperative Day 0 through Day 7
MRI-confirmed intracranial hemorrhage
Measured: From postoperative Day 0 through Day 7
Length of hospital stay
Total number of days from the date of surgery to discharge.
Measured: From postoperative Day 0 through Day 7
Intraoperative fluid volume administered
Total amount of crystalloid and colloid administered during surgery.
Measured: Intraoperative period
Intraoperative vasoactive agent dose
Total dose of vasoactive medications administered during anesthesia.
Measured: Intraoperative period
Intraoperative urine output
Total urine output measured during surgery.
Measured: Intraoperative period
Estimated blood loss
Total estimated blood loss recorded during the surgical procedure.
Measured: Intraoperative period
Duration of anesthesia
Time from induction of anesthesia to completion of anesthesia.
Measured: Intraoperative period
Duration of postoperative mechanical ventilation
Total duration of mechanical ventilation following surgery.
Measured: From end of surgery until extubation, assessed up to 24 hours
Length of ICU stay
Number of days spent in the ICU after surgery.
Measured: From postoperative Day 0 through ICU discharge, assessed up to 14 days
Percentage of anesthesia time with MAP deviating >20% from baseline
Proportion of total anesthesia time during which mean arterial pressure deviates more than 20% from the patient's ward baseline MAP.
Measured: Intraoperative period
Percentage of anesthesia time with cardiac index deviating >20% from baseline
Proportion of total anesthesia time during which cardiac index deviates more than 20% from the patient's baseline cardiac index measured via preoperative echocardiography.
Measured: Intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start2 Dec 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moyamoya DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun-hee Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304947
- Sponsor's protocol ID
- H-2411-122-1591
- Status last verified
- Dec 2025
- First submitted
- 28 Nov 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Cardiac Index-Guided Intraoperative Hemodynamic Management to Improve Postoperative Outcomes in Pediatric Patients With Moyamoya Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07304947
- Acronym / sponsor ID
- H-2411-122-1591
- Conditions
- Moyamoya Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 2 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac index guided hemodynamic management | Experimental | Procedure: Cardiac Index-Guided Hemodynamic Management |
| Blood pressure guided hemodynamic management | Active comparator | Procedure: Blood Pressure-Guided Standard Hemodynamic Management |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pediatric patients <18 years undergoing EDAS for Moyamoya disease under general anesthesia
Key exclusion criteria (4 listed)
- ASA physical status 4-5
- Emergency surgery
- Known cardiovascular disease
- Any condition judged inappropriate by investigators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Index-Guided Hemodynamic ManagementIn 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 or surgery | Cardiac index guided hemodynamic management |
| Blood Pressure-Guided Standard Hemodynamic ManagementIn 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. | Procedure or surgery | Blood pressure guided hemodynamic management |
Primary outcome
Incidence of transient ischemic episodes during hospitalization
Time frame: Postoperative hospital stay
From end of surgery through postoperative hospital discharge, up to 7 days
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Index-Guided Hemodynamic Management and Blood Pressure-Guided Standard Hemodynamic Management in people with Moyamoya Disease, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jung-Bin Park (820220723664, jb4001@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of transient ischemic episodes during hospitalization (time frame: Postoperative hospital stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.