Cerebral Aneurysm Clinical Trial
Official title:
Impact of Intravascular Fluid Resuscitation on Whole Blood Viscosity During Coiling Embolization Procedure for Cerebral Artery Aneurysm
NCT number | NCT02700607 |
Other study ID # | KUH1160101 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2016 |
Est. completion date | June 2017 |
Verified date | July 2019 |
Source | Konkuk University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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=10) and Group-HES (n=10).
All recruited patients will be given patient identification number (PIN) for the present
study of 01-20 according to their order of interview and recruitment. Investigators will
prepare 10 yellow and 10 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 20
(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 < 15
during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture.
Patient data and statistical analyses:
Patient's data whole blood viscosity, PaO2, FiO2, Hemoglobin, urine amount, s-glucose will be
determined from the patients' medical record after patient's discharge.
All statistical analyses will be performed after the 20th patient's discharge and data
acquisition
Status | Completed |
Enrollment | 40 |
Est. completion date | June 2017 |
Est. primary completion date | March 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Konkuk University Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | whole blood viscosity | whole blood viscosity measured by viscometer cm-1 | with 1 hour after the completion of procedure | |
Secondary | PaO2/FiO2 ratio | PaO2/FiO2 ratio measured by arterial blood gas analysis | 1 hour after the completion of procedure | |
Secondary | hematocrit | serum hematocrit, % | 1 hour after the completion of procedure | |
Secondary | glucose | serum glucose level, g/dl | 1 hour after the completion of procedure | |
Secondary | osmolarity | serum osmolarity, mosm | 1 hour after the completion of procedure | |
Secondary | urine output | hourly urine output, ml/hr | 1 hour after the completion of procedure |
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