A Prospective Randomized Controlled Clinical Trial of Standard Compared to Goal-directed Perioperative Fluid Management (GDT) for Patients Undergoing Liver Resection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Postoperative Complications
研究概览
简要总结
The purpose of this study is to help us learn what is the best amount of fluid to administer to patients during liver surgery. Patients will receive either an amount for this surgery based on weight, blood pressure, heart rate and urine output or an amount guided by a computerized system (FloTrac) that helps doctors know how much fluid each patient needs. The FloTrac calculates the amount of fluid patients needs on a minute-to-minute basis, based on real time information like blood pressure, pulse and the ability of the heart and blood vessels to maintain normal vital signs.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (18 years old or greater) who are able to provide informed consent.
- •Patients who undergo an open, elective liver resection. Including those initially approached laparoscopically but converted to an open resection and those undergoing additional procedures.
排除标准
- •Active coronary disease.
- •Patients with a history of coronary disease will be eligible if they have had a cardiac stress study showing no reversible ischemia and normal LV function within 3 months of operation.
- •Active symptomatic cerebrovascular disease.
- •Active congestive heart failure and ejection fraction <35%.
- •Active severe restrictive or obstructive pulmonary disease and resting SpO2 <90%.
- •Active renal dysfunction (Cr >1.8)
- •Abnormal coagulation parameters (INR > 1.8 not on Coumadin, or platelet count < 100,000 per mcL)
- •Presence of active infection including HIV
- •Patients with active atrial fibrillation or flutter.
- •Preoperative hypoalbuminemia (Albumin < 2g/dl).
- •Female patients who are pregnant (female patients of child-bearing potential must have a negative serum pregnancy test ≤ 14 days prior to surgery or 15 to 30 days prior to surgery with a negative urine pregnancy test the morning of surgery).
- •Presence of ascites.
- •BMI > 45 or <17
研究组 & 干预措施
Standard fluid management
Prospective single-blinded randomized trial. Eligible patients will be consented for the trial prior to surgery. However randomization will not occur until the operating room. After the liver has been resected, intraoperative randomization will be done by envelopes.
干预措施: Standard fluid management (Procedure)
Goal directed fluid therapy
Prospective single-blinded randomized trial. Eligible patients will be consented for the trial prior to surgery. However randomization will not occur until the operating room. After the liver has been resected, intraoperative randomization will be done by envelopes.
干预措施: Goal directed fluid therapy with the Edwards EV1000 system (Device)
结局指标
主要结局
Postoperative Complications
时间窗: 30 days post procedure
The incidence of overall 30-day postoperative complications will be recorded. These are defined in the MSKCC Adverse Events Program and organized by categories reflecting organ systems and further subdivided into specific complications within those and graded.
次要结局
- Total Volume of Fluid Used Postoperatively(Postoperatively for the total admission time, up to 8 days)
- Total Volume of Fluid Used Perioperatively(Up to the first 72 hours postoperatively)
- Postoperative Length of Stay(Postoperatively for the total admission time, up to 8 days)
- Low Cardiac Output Time(Up to the first 24 postoperative hours)