Recruiting
Phase 2

Hypertonic Saline

Sponsor:

Thomas Jefferson University

Code:

NCT01428050

Conditions

Pancreaticoduodenectomy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

3% NaCl Solution

Lactated Ringers Solution

Study Details

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 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.

Conditions

Pancreaticoduodenectomy

Study ID

NCT01428050

Start date

May, 2011

Status verified date

Mar, 2015

Completion date

Dec, 2015

Anticipated

Primary completion date

Jun, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

264 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 3% saline

Patients will received 3% saline in conjunction with lactated ringers solution intra and post operatively for a net reduction in total fluid administration

active comparator: Lactated Ringers

15cc/kg/hr of lactated ringers solution intraoperatively

Interventions

3% NaCl Solution

1cc/kg/hr of 3%NaCl + 9cc/kg/hr of lactated ringers solution

Lactated Ringers Solution

15cc/kg/hr for intraoperative fluids

Primary outcome measure

  • Anastomotic Leak [ Time Frame: 30 days ]
  • Delayed Gastric Emptying [ Time Frame: 30 days ]
  • Myocardial Infarction [ Time Frame: 30 days ]
  • Pneumonia [ Time Frame: 30 days ]
  • Wound Infection [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Locations

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

More Information

Sponsor

Thomas Jefferson University

Last update posted

Mar 18, 2015

Last verified

Mar, 2015

Keywords

  • whipple
  • hypertonic saline
  • pancreaticoduodenectomy
  • fluid restriction
  • resuscitation strategy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2015-03-18.