Stroke Volume Variation- Guided Hemodynamic Therapy Versus Oxygen Extraction Ratio-guided Hemodynamic Therapy on Outcomes Following Laparoscopic Gastrointestinal Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 610
- 主要终点
- postoperative complication
研究概览
简要总结
The FloTrac/Vigileo is a minimal invasive device assessing flow based hemodynamic parameters by pulse contour analysis based on the radial artery pressure signal. This method gained popularity as it is minimally invasive compared to esophageal Doppler or pulmonary artery catheter insertion and provides continuous beat-to-beat data. The previous study with 110 patients found that that GDHT guided by stroke volume variation (SVV) using the FloTrac/Vigileo device was associated with a reduced length of hospital stay and a lower incidence of POGD in major abdominal oncological surgery. However, no difference was found in the incidence of postoperative complications between the two groups, lack of statistical power could be a limitation to demonstrate the true association. Therefore, further prospective trials are needed to address this issue.
The use of early and efficient therapeutic strategies able to detect and to treat potential triggers of organ failures, such as tissue hypoperfusion, is particularly important. If hypoperfusion is not adequately managed, tissue hypoxia could occur, resulting from an impairment of the adaptive mechanisms of myocardial contractile function, under the influence of inflammatory mediators, and the peripheral tissues will then increase their oxygen extraction (O2ER). AS such, GDHT guided by O2ER may be appropriate to monitor GDHT strategies because it reflects the balance between oxygen delivery and consumption.
Therefore, the investigators performed this single-center, randomized, controlled trial to investigate whether GDHT guided by SVV using FloTrac/Vigileo monitor and GDHT guided by O2ER would reduce incidence of postoperative complication and shorten the length of hospital stay, compared with a standard conventional fluid therapy in low-to-moderate risk patients undergoing major laparoscopic gastrointestinal oncological surgery.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18~80 years
- •Patients undergoing elective major laparoscopic gastrointestinal oncological surgery.Procedures were considered major if listed for resection cancer with tumor debulking, staging or reconstruction with a risk for significant surgical blood loss.
排除标准
- •co-existing congestive heart failure; chronic lung disease; or renal or hepatic dysfunction (creatinine >50 % or liver enzymes >50 % of normal values), and arrhythmias.
- •less than 18 years
- •pregnant or lactating woman
- •patients undergoing emergency surgery
结局指标
主要结局
postoperative complication
时间窗: 30 days after surgery
the number of patients with predefined moderate or major postoperative complications (pulmonary embolism, myocardial ischemia or infarction, arrhythmia, cardiac or respiratory arrest, limb or digital ischemia, cardiogenic pulmonary edema, acute respiratory distress syndrome, gastrointestinal bleeding, bowel infarction, anastomotic breakdown, paralytic ileus, acute psychosis, stroke, acute kidney injury, infection \[source uncertain\], urinary tract infection, surgical site infection, organ/space infection, bloodstream infection, nosocomial pneumonia, and postoperative hemorrhage
次要结局
- mortality(all-cause mortality at 30 days following surgery; all-cause mortality at 180 days following surgery)
- Length of hospital stay(from the end of surgery until the date of discharge from hospital,assessed up to 30 days after surgery)
- postoperative recovery quality(1, 3, 7 days after surgery)
- critical care-freedays(30 days after surgery)
- time to first tolerate of an oral diet(from the end of surgery until the date of discharge from hospital,assessed up to 30 days after surgery)
- time to first flatus(from the end of surgery until the date of discharge from hospital,assessed up to 30 days after surgery)
研究者
YANXIA SUN
Principal Investigator
Beijing Tongren Hospital