Impact of Intravascular Fluid Resuscitation and Whole Blood Viscosity for CABG Surgery

Overview

After obtaining approval from the Institutional Review Board of our institution, written informed consent is obtained from patients undergoing CABG surgery 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 30 thick-paper envelopes. Then, all envelopes will be sealed, mixed and randomly allocated to get numbers of 01 to 30 (Envelop number). 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 30th patient's discharge and data acquisition

Full Title of Study: “Impact of Intravascular Fluid Resuscitation on Whole Blood Viscosity During CABG Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: October 2016

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • whole blood viscosity
    • Time Frame: with 1 hour after the completion of procedure
    • whole blood viscosity measured by viscometer cm-1

Secondary Measures

  • PaO2/FiO2 ratio
    • Time Frame: with 1 hour after the completion of procedure
    • PaO2/FiO2 ratio measured by arterial blood gas analysis
  • hematocrit
    • Time Frame: with 1 hour after the completion of procedure
    • serum hematocrit, %
  • glucose
    • Time Frame: with 1 hour after the completion of procedure
    • serum glucose level, g/dl
  • osmolarity
    • Time Frame: with 1 hour after the completion of procedure
    • serum osmolarity, mOsm
  • urine output
    • Time Frame: with 1 hour after the completion of procedure
    • hourly urine output, ml/hr
  • Maximum clot formation
    • Time Frame: with 1 hour after the completion of procedure
    • Maximum clot formation in rotational thromboelastometry (ROTEM) analysis, mm

Participating in This Clinical Trial

Inclusion Criteria

  • Patients undergoing CABG Surgery – 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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Konkuk University Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Tae-Yop Kim, MD PhD, Professor – Konkuk University Medical Center
  • Overall Contact(s)
    • Tae-Yop Kim, MD, PhD, 82-2-2030-5448, taeyop@gmail.com

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