Impact of Intravascular Fluid Resuscitation and Whole Blood Viscosity
Primary Purpose
Cerebral Aneurysm
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intravenous Crystalloid
Intravenous HES
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Aneurysm focused on measuring cerebral aneurysm, coiling embolization, blood viscosity
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Intravenous Crystalloid
Intravenous HES
Arm Description
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
Outcomes
Primary Outcome Measures
whole blood viscosity
whole blood viscosity measured by viscometer cm-1
Secondary Outcome Measures
PaO2/FiO2 ratio
PaO2/FiO2 ratio measured by arterial blood gas analysis
hematocrit
serum hematocrit, %
glucose
serum glucose level, g/dl
osmolarity
serum osmolarity, mosm
urine output
hourly urine output, ml/hr
Full Information
NCT ID
NCT02700607
First Posted
February 23, 2016
Last Updated
July 17, 2019
Sponsor
Konkuk University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02700607
Brief Title
Impact of Intravascular Fluid Resuscitation and Whole Blood Viscosity
Official Title
Impact of Intravascular Fluid Resuscitation on Whole Blood Viscosity During Coiling Embolization Procedure for Cerebral Artery Aneurysm
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konkuk University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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=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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Aneurysm
Keywords
cerebral aneurysm, coiling embolization, blood viscosity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intravenous Crystalloid
Arm Type
Placebo Comparator
Arm Description
crystalloid is administered to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture
Arm Title
Intravenous HES
Arm Type
Active Comparator
Arm Description
HES is administered to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture
Intervention Type
Drug
Intervention Name(s)
Intravenous Crystalloid
Intervention Description
crystalloid is administered to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture
Intervention Type
Drug
Intervention Name(s)
Intravenous HES
Intervention Description
HES is administered to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture
Primary Outcome Measure Information:
Title
whole blood viscosity
Description
whole blood viscosity measured by viscometer cm-1
Time Frame
with 1 hour after the completion of procedure
Secondary Outcome Measure Information:
Title
PaO2/FiO2 ratio
Description
PaO2/FiO2 ratio measured by arterial blood gas analysis
Time Frame
1 hour after the completion of procedure
Title
hematocrit
Description
serum hematocrit, %
Time Frame
1 hour after the completion of procedure
Title
glucose
Description
serum glucose level, g/dl
Time Frame
1 hour after the completion of procedure
Title
osmolarity
Description
serum osmolarity, mosm
Time Frame
1 hour after the completion of procedure
Title
urine output
Description
hourly urine output, ml/hr
Time Frame
1 hour after the completion of procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
No
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Impact of Intravascular Fluid Resuscitation and Whole Blood Viscosity
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