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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
Konkuk University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Aneurysm focused on measuring cerebral aneurysm, coiling embolization, blood viscosity

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 23, 2016
    Last Updated
    July 17, 2019
    Sponsor
    Konkuk University Medical Center
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    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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