NCT01428050

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 264 (estimated)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	3% NaCl Solution	1cc/kg/hr of 3%NaCl + 9cc/kg/hr of lactated ringers solution
DRUG	Lactated Ringers Solution	15cc/kg/hr for intraoperative fluids

Timeline

• Start date: 2011-05-01
• Primary completion: 2015-06-01
• Completion: 2015-12-01
• First posted: 2011-09-02
• Last updated: 2015-03-18

Locations

1 site across 1 country: United States