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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pancreaticoduodenectomy

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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