Status:

UNKNOWN

The Use of a Restrictive Fluid Regimen With Hypertonic Saline for Patients Undergoing Pancreaticoduodenectomy

Lead Sponsor:

Thomas Jefferson University

Conditions:

Pancreaticoduodenectomy

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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 ca...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

May 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2015

Estimated Enrollment :

264 Patients enrolled

Trial Details

Trial ID

NCT01428050

Start Date

May 1 2011

End Date

December 1 2015

Last Update

March 18 2015

Active Locations (1)

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1

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States, 19107