Trial Information
Prospective Randomized Controlled Trial on the Use of a Restrictive Fluid Regimen With Hypertonic Saline for Patients Undergoing Pancreaticoduodenectomy
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Anastomotic Leak
Outcome Description:
Leak or defect of gastrointestinal anastomosis including but not limited to pancreaticojejunostomy
Outcome Time Frame:
30 days
Safety Issue:
No
Principal Investigator
Harish Lavu, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Thomas Jefferson University
Authority:
United States: Institutional Review Board
Study ID:
Jefferson Hypertonic
NCT ID:
NCT01428050
Start Date:
May 2011
Completion Date:
December 2013
Related Keywords:
- Pancreaticoduodenectomy
- whipple
- hypertonic saline
- pancreaticoduodenectomy
- fluid restriction
- resuscitation strategy
Name | Location |
Thomas Jefferson University Hospital |
Philadelphia, Pennsylvania 19131 |