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

Konkuk University Medical Center

Status: Unknown

Conditions: Cardiac Surgery

Treatments: Drug: Intravenous HES; Drug: Intravenous Crystalloid

Study type: Interventional

Funder types: Other

Identifiers

NCT02757118

KUH000011

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients undergoing coiling embolization procedure due to cardiac 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
• Patients received or receiving intraoperative and preoperative blood salvaged, allogenic blood transfusion, anti-platelet drug, anti-fibrinolytic agents or recombinant human erythropoietin, or undergoing cardiac surgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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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