Impact of Intravascular Fluid Resuscitation on Whole Blood Viscosity During Cardiac Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- whole blood viscosity
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Intravenous Crystalloid
crystalloid is administered to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture
干预措施: Intravenous Crystalloid (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
干预措施: Intravenous HES (Drug)
结局指标
主要结局
whole blood viscosity
时间窗: with 1 hour after the completion of procedure
次要结局
- hematocrit(with 1 hour after the completion of procedure)
- PaO2/FiO2 ratio(with 1 hour after the completion of procedure)
- glucose(with 1 hour after the completion of procedure)
- osmolarity(with 1 hour after the completion of procedure)
- urine output(with 1 hour after the completion of procedure)
- Maximum clot formation(with 1 hour after the completion of procedure)
研究者
Tae-Yop Kim, MD PhD
Professor
Konkuk University Medical Center