The Effects of Two Hemodilution Methods on Vascular Endothelial Function in Patients Undergoing Primary Debulking Gynaecological Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 主要终点
- Endothelin-1 (ET-1)
研究概览
简要总结
Primary cytoreductive surgery for ovarian cancer is an ideal setting to evaluate endothelial function under ANH and AHH, as the procedure is associated with moderately high blood loss. As the technique has not yet been described in this setting, investigators designed a pilot study to evaluate ANH and AHH in patients planned to undergo primary cytoreduction during perioperative period, with the intent of proceeding to a randomized trial if results were favorable.
详细描述
Using a computer-generated random number table, patients were randomized to three groups: Control Group(n=30), ANH Group(n=30) and AHH Group(n=30). Patients underwent standard preoperative preparation for cytoreductive surgery according to institutional standards.All patients who underwent a standard anesthesia protocol and similar surgical procedures were considered for the analysis. For this purpose, investigators only included patients who underwent the following interventions: radical hysterectomy, bilateral adnexectomy, one or more bowel resection, peritonectomy, pelvic lymphadenectomy and extended periaortic lymphadenectomy. The patient would be ruled out of the experiment when the participant was accompanied with any kind of serious complications such as wakening delay and drug allergy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of advanced primary epithelial ovarian
- •No comorbidities nor functional limitations (ASA Grade II due to high tumor load)
- •Serum hemoglobin (Hb) before surgery ≥ 11g/dl
- •Hematocrit (Hct) ≥ 35%
- •Quantity of platelets ≥ 100 × 109 /L
排除标准
- •Age <18 or >65 years
- •Body mass index <20 and >30 kg/m2
- •Duration of surgery <180 min
- •Severe cardiovascular disease, liver and kidney disease
- •Thromboembolism history
研究组 & 干预措施
Control Group
In control group ，patients had undergone similar surgical and anesthesia procedures in the same time period but whose hemodynamic management was carried out according to the clinical decision of the attending anesthesiologist.
acute normovolemic hemodilution (ANH)
Before anesthesia induction, in the ANH Group, blood was withdrawn at a speed of 25-30ml/min from radial artery and stored in standard collection bags. The volume of blood to be removed during ANH was calculated using an established formula as follows: V = EBV (H0 - Ht) / H. During collection, a tilt rocker scale was used to rock, mix, and weigh the blood. To maintain euvolemia, half of the blood volume removed was replaced with 6% hydroxyethyl starch 130/0.4 with medium molecular weight at a 1:1 ratio and half was replaced with crystalloid at a 1:2 ratio. The autologous blood was returned to patients if the intraoperative transfusion trigger (Hb <8.0g/dl) was reached or at the completion of the operation.
干预措施: acute normovolemic hemodilution (ANH) (Other)
acute hypervolemic hemodilution (AHH)
In AHH group, 15ml/kg Voluven was transfused at a speed of 30 ml/min to make Hct to drop to medium. In control group, the regular transfusion and infusion were conducted. Allogenic blood was only given after all autologous blood had been returned to the patient. The transfusion triggers (Hb <8.0g/dl) were used to determine the need for allogenic blood transfusions during the procedure in three groups.
干预措施: acute hypervolemic hemodilution (AHH) (Other)
结局指标
主要结局
Endothelin-1 (ET-1)
时间窗: three periods: before hemodilution, immediate postoperative period, and 24 hours later
Blood sample (5 ml) was obtained from the vein，Endothelin-1 (ET-1) was measured using the enzyme-linked immunosorbent assay (ELISA) (Merck \& Co Inc, USA) according to manufacturer's instructions.
次要结局
- von Willebrand factor (VWF), tissue factor pathway inhibitor (TFPI), plasminogen activator inhibitor 1 (PAI-1) and thrombomodulin (TM) levels(three periods: before hemodilution, immediate postoperative period, and 24 hours later)
研究者
Zhou Huidan
Clinical Professor
Zhejiang Cancer Hospital