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

Phase 2

• Conditions: Pancreaticoduodenectomy
• Interventions: Drug: 3% NaCl Solution; Drug: Lactated Ringers Solution

• Registration Number: NCT01428050
• Lead Sponsor: Thomas Jefferson University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-08-31
• Study First Submitted QC: 2011-09-01
• Study First Posted: 2011-09-02
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-18
• Primary Completion: 2015-06
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 264

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3% saline	3% NaCl Solution	Patients will received 3% saline in conjunction with lactated ringers solution intra and post operatively for a net reduction in total fluid administration
Lactated Ringers	Lactated Ringers Solution	15cc/kg/hr of lactated ringers solution intraoperatively

Primary Outcome Measures

Name	Time	Method
Delayed Gastric Emptying	30 days	Rate of delayed gastric emptying post procedure, prolonged initiation of enteral feeding
Myocardial Infarction	30 days
Anastomotic Leak	30 days	Leak or defect of gastrointestinal anastomosis including but not limited to pancreaticojejunostomy
Wound Infection	30 days
Pneumonia	30 days

Trial Locations

Locations (1)

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States