The Use of a Restrictive Fluid Regimen With Hypertonic Saline for Patients Undergoing Pancreaticoduodenectomy
Status unconfirmed · Phase 2
Conditions studied: Pancreaticoduodenectomy
In brief
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.
Key facts
- Study ID
- NCT01428050
- Run by
- Thomas Jefferson University
- People needed
- 264
- Starts
- 2011-05-01
- Expected to finish
- 2015-12-01
- Last updated by the study team
- 2015-03-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Metabolic acidosis
- Active Sepsis or Bacteremia
- Chronic renal insufficiency
- Hyponatremia (serum sodium <130)
- Hypernatremia (serum sodium >150)
- Pregnancy
- Sickle cell anemia
- Pediatric patients
- BMI>40
Where it is running
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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