Cardiac Surgery Clinical Trial
Official title:
Impact of Intravascular Fluid Resuscitation on Whole Blood Viscosity During Cardiac Surgery
After obtaining approval from the Institutional Review Board of our institution, written
informed consent is obtained from patients undergoing cardiac 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). 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 30th patient's discharge and data
acquisition
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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