Clinical trial NCT02757118: Impact of Intravascular Fluid Resuscitation and Whole Blood Viscosity for Cardiac Surgery
Official title: Impact of Intravascular Fluid Resuscitation on Whole Blood Viscosity During Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Surgery
Keywords: Cardiac Surgery, blood viscosity
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2016-04-29
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
measure: whole blood viscosity
timeFrame: with 1 hour after the completion of procedure
Secondary outcomes:
measure: PaO2/FiO2 ratio
timeFrame: with 1 hour after the completion of procedure
measure: hematocrit
timeFrame: with 1 hour after the completion of procedure
measure: glucose
timeFrame: with 1 hour after the completion of procedure
measure: osmolarity
timeFrame: with 1 hour after the completion of procedure
measure: urine output
timeFrame: with 1 hour after the completion of procedure
measure: Maximum clot formation
timeFrame: with 1 hour after the completion of procedure
Other outcomes:
Locations:
Study officials:
References: