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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01428050

Enrollment

264

Registered

2011-09-02

Start date

2011-05-31

Completion date

2015-12-31

Last updated

2015-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreaticoduodenectomy

Keywords

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

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.

Interventions

DRUG3% NaCl Solution

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

DRUGLactated Ringers Solution

15cc/kg/hr for intraoperative fluids

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Contacts

Primary ContactHarish Lavu, MD

harish.lavu@jeffersonhospital.org215-955-9402

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026