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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01428050
• Other study ID #: Jefferson Hypertonic
• Status: Recruiting
• Phase: Phase 2
• First received: August 31, 2011
• Last updated: March 17, 2015
• Start date: May 2011
• Est. completion date: December 2015

Study information

• Verified date: March 2015
• Source: Thomas Jefferson University
• Contact: Harish Lavu, MD
• Phone: 215-955-9402
• Email: harish.lavu[@]jeffersonhospital.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Pancreaticoduodenectomy

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anastomotic Leak	Leak or defect of gastrointestinal anastomosis including but not limited to pancreaticojejunostomy	30 days	No
Primary	Delayed Gastric Emptying	Rate of delayed gastric emptying post procedure, prolonged initiation of enteral feeding	30 days	No
Primary	Myocardial Infarction		30 days	Yes
Primary	Pneumonia		30 days	No
Primary	Wound Infection		30 days	No