Prospective Randomized Controlled Trial on the Use of a Restrictive Fluid Regimen With Hypertonic Saline for Patients Undergoing Pancreaticoduodenectomy
试验速览
- 阶段
- 2 期
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Delayed Gastric Emptying
研究概览
简要总结
The Whipple operation is a complex surgical procedure involving the removal of the head of the pancreas, bile duct, and a portion of the intestine (duodenum) that is performed for patients who have cancer or some other condition affecting this region of the body. The Whipple operation is associated with a significant complication rate. Previous studies have shown that in a broad range of surgical procedures, using a reduced amount of intravenous fluids along with a special type of fluid called hypertonic saline during and after the procedure can lower complication rates associated with the heart and lungs during recovery from surgery. The purpose of this study is to determine if using a reduced amount of intravenous fluids as well as hypertonic saline (a salt concentrated form of intravenous fluids) during the Whipple operation and in the immediate period after surgery can reduce complications.
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
- None
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
- •Physiologic suitability for major abdominal surgery
- •Aged 18 years and older
- •Written informed consent
- •Ability to understand and comply with study guidelines
- •Ability to obtain a central venous line
排除标准
- •Metabolic acidosis
- •Active Sepsis or Bacteremia
- •Chronic renal insufficiency
- •Hyponatremia (serum sodium <130)
- •Hypernatremia (serum sodium >150)
- •Pregnancy
- •Sickle cell anemia
- •Pediatric patients
研究组 & 干预措施
Lactated Ringers
15cc/kg/hr of lactated ringers solution intraoperatively
干预措施: Lactated Ringers Solution (Drug)
3% saline
Patients will received 3% saline in conjunction with lactated ringers solution intra and post operatively for a net reduction in total fluid administration
干预措施: 3% NaCl Solution (Drug)
结局指标
主要结局
Delayed Gastric Emptying
时间窗: 30 days
Rate of delayed gastric emptying post procedure, prolonged initiation of enteral feeding
Myocardial Infarction
时间窗: 30 days
Pneumonia
时间窗: 30 days
Anastomotic Leak
时间窗: 30 days
Leak or defect of gastrointestinal anastomosis including but not limited to pancreaticojejunostomy
Wound Infection
时间窗: 30 days
次要结局
未报告次要终点
