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

Pancreaticoduodenectomy Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pancreaticoduodenectomy

• NCT number: NCT01428050
• Study type: Interventional
• Source: Thomas Jefferson University
• Contact: Harish Lavu, MD
• Phone: 215-955-9402
• Email: harish.lavu@jeffersonhospital.org
• Status: Recruiting
• Phase: Phase 2
• Start date: May 2011
• Completion date: December 2015