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

K

Konkuk University Medical Center

Status

Unknown

Conditions

CABG Surgery

Treatments

Drug: Intravenous HES
Drug: Intravenous Crystalloid

Study type

Interventional

Funder types

Other

Identifiers

NCT02757027
KUH000012

Details and patient eligibility

About

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

Enrollment

30 estimated patients

Sex

All

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 2 patient groups, including a placebo group

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

Trial contacts and locations

0

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Central trial contact

Tae-Yop Kim, MD, PhD

Data sourced from clinicaltrials.gov

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