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Impact of Intravascular Fluid Resuscitation and Whole Blood Viscosity

Impact of Intravascular Fluid Resuscitation on Whole Blood Viscosity During Coiling Embolization Procedure for Cerebral Artery Aneurysm

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02700607
Enrollment
40
Registered
2016-03-07
Start date
2016-06-30
Completion date
2017-06-30
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Aneurysm

Keywords

cerebral aneurysm, coiling embolization, blood viscosity

Brief summary

After obtaining approval from the Institutional Review Board of our institution, written informed consent is obtained from patients undergoing interventional cerebral aneurysm coiling procedure are enrolled in this prospective study and randomly allocated into one of two groups: Group-C (n=15) and Group-HES (n=15). All recruited patients will be given patient identification number (PIN) for the present study of 01-30 according to their order of interview and recruitment. Investigators will prepare 15 yellow and 15 green cards, which will be inserted in 20 thick-paper envelopes. Then, all envelopes will be sealed, mixed and randomly allocated to get numbers of 01 to 30 (Envelop number). After printing the envelope number outside envelope, all sealed envelopes with cards will be conveyed to and kept in pharmacy department. According to the color of the card, attending anesthesiologists will give crystalloid for yellow card or HES for green cards, respectively, to maintain stroke volume variation lesser than 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture. Patient data and statistical analyses: Patients demographic data, whole blood viscosity, PaO2, FiO2, Hemoglobin, urine amount, s-glucose will be obtained

Interventions

crystalloid is administered to maintain stroke volume variation \< 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture

HES is administered to maintain stroke volume variation \< 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture

Sponsors

Konkuk University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients undergoing coiling embolization procedure due to cerebral aneurysm * Patients provided a written informed consent. * Patients with preoperative serum hemoglobin concentration \>13 g/dL (male) and \>12 g/dL (female) * Patients with PaO2/FiO2 ratio \>150

Exclusion criteria

* Patients with history of anemia, dyspnea, active infection. * Patients with endocrine disease * Patients received or receiving intraoperative and preoperative blood salvaged, allogenic blood transfusion, anti-platelet drug, anti-fibrinolytic agents or recombinant human erythropoietin, or undergoing acute normovolemic hemodilution.

Design outcomes

Primary

MeasureTime frameDescription
whole blood viscositywith 1 hour after the completion of procedurewhole blood viscosity measured by viscometer cm-1

Secondary

MeasureTime frameDescription
PaO2/FiO2 ratio1 hour after the completion of procedurePaO2/FiO2 ratio measured by arterial blood gas analysis
hematocrit1 hour after the completion of procedureserum hematocrit, %
glucose1 hour after the completion of procedureserum glucose level, g/dl
osmolarity1 hour after the completion of procedureserum osmolarity, mosm
urine output1 hour after the completion of procedurehourly urine output, ml/hr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026