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临床试验/NCT01428050
NCT01428050Unknown2 期

Prospective Randomized Controlled Trial on the Use of a Restrictive Fluid Regimen With Hypertonic Saline for Patients Undergoing Pancreaticoduodenectomy

Thomas Jefferson University1 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2011年5月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

15cc/kg/hr of lactated ringers solution intraoperatively

干预措施: Lactated Ringers Solution (Drug)

3% saline

Experimental

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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