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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pancreaticoduodenectomy

Intervention / Treatment
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* Drug: 3% NaCl Solution
* Drug: Lactated Ringers Solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3% saline<br>Patients will received 3% saline in conjunction with lactated ringers solution intra and post operatively for a net reduction in total fluid administration | Drug: 3% NaCl Solution<br>* 1cc/kg/hr of 3%NaCl + 9cc/kg/hr of lactated ringers solution<br>|
| Active Comparator: Lactated Ringers<br>15cc/kg/hr of lactated ringers solution intraoperatively | Drug: Lactated Ringers Solution<br>* 15cc/kg/hr for intraoperative fluids<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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whipple, hypertonic saline, pancreaticoduodenectomy, fluid restriction, resuscitation strategy