Impact of Intravascular Fluid Resuscitation and Whole Blood Viscosity

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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

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
    



Study Type

Interventional


Primary Outcome

whole blood viscosity

Secondary Outcome

 PaO2/FiO2 ratio

Condition

Cerebral Aneurysm

Intervention

Intravenous Crystalloid

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

40

Start Date

June 2016

Completion Date

June 2017

Primary Completion Date

March 2017

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.
      

Gender

All

Ages

19 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 



Administrative Informations


NCT ID

NCT02700607

Organization ID

KUH1160101


Responsible Party

Principal Investigator

Study Sponsor

Konkuk University Medical Center


Study Sponsor

, , 


Verification Date

July 2019