Comparison of the Effects of Hydroxyethyl Starch and Ringer's Lactate on Blood Loss and Coagulation After Colorectal Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Prothrombin Time (PT) Measurement
研究概览
简要总结
Infusion of intravenous fluids is mandatory especially in major and prolonged surgeries. However, there is no available optimum ideal type of fluid nor a fixed amount suitable for transfusion but it must be individualized for every patient to minimize the side effects of fluids.
Ringer's lactate as an example of crystalloids, causes a transient hypercoagulable state after its infusion, disappears in less than 6 hours of infusion and the coagulation profile returns to its state before Ringer's.
Voluven (Hydroxyehthyl starch 130/0.4) a colloid causes a hypocoagulable state after its infusion, and its effect is prolonged to more than 6 hours after infusion.
The effects of hydroxyethyl starch are not dose-dependent, but they can be remarkable even with mild to moderate amount of blood dilution applying nearly a restrictive fluid transfusion strategy and a goal-directed fluid therapy mode.
The amount of needed crystalloids is much more than that of colloids to maintain patients hemodynamically stable.
详细描述
When considering the optimum fluid of choice to achieve hemodynamic stability and the least morbidity, colloids have a theoritical and intuitive advantage. Being composed of molecules >35 kDa, colloids have traditionally been thought to have greater fluid efficacy (i.e. they remain in the intravascular space for longer ,thus contributing a greater effect on cardiac output) compared with crystalloids. These theoritical benefits of colloids led to their routine use in goal-directed therapy (GDT).
Studies in healthy volunteers have demonstrated that crystalloids tend to expand the intravascular volume by about 20% of the infused volume ;however when physiological endpoints have been used in clinical studies , the fluid efficacy of crystalloids increases up to 60%. This discrepancy may be explained by a number of factors, including the time taken for fluid to equilibrate throughout the extracellular fluid , the vaodilating effect of anethetic-indused hypotension on vascular capacitance, and the impairment of fluid elimination because of the surgical stress response.
While colloid has been the default fluid choice in most GDT studies to date, recent evidence from both the perioperative anesthestic setting and from intensive care have raised concerns that these agents may produce adverse effects on renal function and coagulation . recent studies have sought to compare the use of crystalloid solutions with colloids for GDT.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 to 75 years
- •undergoing elective colorectal surgery
排除标准
- •refusal by the patient
- •patient with cardiac disease
- •hepatic disease
- •renal disease
- •blood disease
- •patient on regular anticoagulant drug
结局指标
主要结局
Prothrombin Time (PT) Measurement
时间窗: Baseline just after induction, at end of infusion, and 6 hours post-operative.
Measurement of Prothrombin Time to assess the effect of colloid and crystalloid administration on clotting time. Unit of Measure: seconds. Measurement Tool: laboratory tests were all supplied by technology of Marburg, Germany using Sysmex Cs 2100i, code (THL-02) with serial number 22880.
International Normalized Ratio (INR)
时间窗: baseline just after induction, at end of infusion, 6 hours post-operative.
Calculation of International Normalized Ratio to standardize clotting time measurements and evaluate the effect of fluid type on coagulation. Unit of Measure: ratio. Measurement Tool: laboratory tests were all supplied by technology of Marburg, Germany using Sysmex Cs 2100i, code (THL-02) with serial number 22880.
Activated Partial Thromboplastin Time (aPTT)
时间窗: baseline just after induction, at end of infusion, 6 hours post-operative.
Measurement of Activated Partial Thromboplastin Time to assess the intrinsic coagulation pathway after administration of colloid or crystalloid. Unit of Measure: seconds. Measurement Tool: laboratory tests were all supplied by technology of Marburg, Germany using Sysmex Cs 2100i, code (THL-02) with serial number 22880.
Factor V Levels
时间窗: baseline just after induction, at end of infusion, 6 hours post-operative.
Measurement of plasma levels of coagulation Factor V to evaluate changes in coagulation function following fluid administration. Unit of Measure: International Units per deciliter (IU/dL). Measurement Tool: laboratory tests were all supplied by technology of Marburg, Germany using Sysmex Cs 2100i, code (THL-02) with serial number 22880.
Factor VIII Levels
时间窗: Baseline just after induction, at end of infusion, 6 hours post-operative.
Plasma level measurement of coagulation Factor VIII to assess the impact of colloid and crystalloid on coagulation. Unit of Measure: International Units per deciliter (IU/dL). Measurement Tool: laboratory tests were all supplied by technology of Marburg, Germany using Sysmex Cs 2100i, code (THL-02) with serial number 22880.
Factor IX Levels
时间窗: Baseline just after induction, at end of infusion, 6 hours post-operative.
Measurement of coagulation Factor IX levels in plasma to assess any changes in the clotting profile after fluid administration. Unit of Measure: International Units per deciliter (IU/dL). Measurement Tool: laboratory tests were all supplied by technology of Marburg, Germany using Sysmex Cs 2100i, code (THL-02) with serial number 22880.
Blood Loss Volume
时间窗: Total volume recorded at the end of the surgical procedure.
Measurement of total blood loss volume to compare the effects of colloid and crystalloid solutions on hemostasis. Blood loss is calculated using the method outlined by Choi et al. (2010), which includes the volume in suction (minus irrigation fluid), visible blood on the surgical field, and blood absorbed in surgical pads. Surgical pads are estimated by inspection, with fully soaked pads counted as 150 mL and half-soaked pads as 100 mL. Unit of Measure: milliliters (mL).
次要结局
- Blood transfusion requirements(Total units required recorded at the end of the surgical procedure.)
研究者
Sara Usama Mohammed Rabie
Assistant Lecturer
Assiut University