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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2015-12-31

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.

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Detailed Description

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Conditions

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Pancreaticoduodenectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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3% saline

Patients will received 3% saline in conjunction with lactated ringers solution intra and post operatively for a net reduction in total fluid administration

Group Type EXPERIMENTAL

3% NaCl Solution

Intervention Type DRUG

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

Lactated Ringers

15cc/kg/hr of lactated ringers solution intraoperatively

Group Type ACTIVE_COMPARATOR

Lactated Ringers Solution

Intervention Type DRUG

15cc/kg/hr for intraoperative fluids

Interventions

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3% NaCl Solution

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

Intervention Type DRUG

Lactated Ringers Solution

15cc/kg/hr for intraoperative fluids

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No