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

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ClinicalTrials.gov Identifier: NCT01428050
Recruitment Status : Unknown
Verified March 2015 by Thomas Jefferson University.
Recruitment status was:  Recruiting
First Posted : September 2, 2011
Last Update Posted : March 18, 2015
Information provided by (Responsible Party):
Thomas Jefferson University

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.

Condition or disease Intervention/treatment Phase
Pancreaticoduodenectomy Drug: 3% NaCl Solution Drug: Lactated Ringers Solution Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prospective Randomized Controlled Trial on the Use of a Restrictive Fluid Regimen With Hypertonic Saline for Patients Undergoing Pancreaticoduodenectomy
Study Start Date : May 2011
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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
Drug: 3% NaCl Solution
1cc/kg/hr of 3%NaCl + 9cc/kg/hr of lactated ringers solution

Active Comparator: Lactated Ringers
15cc/kg/hr of lactated ringers solution intraoperatively
Drug: Lactated Ringers Solution
15cc/kg/hr for intraoperative fluids

Primary Outcome Measures :
  1. Anastomotic Leak [ Time Frame: 30 days ]
    Leak or defect of gastrointestinal anastomosis including but not limited to pancreaticojejunostomy

  2. Delayed Gastric Emptying [ Time Frame: 30 days ]
    Rate of delayed gastric emptying post procedure, prolonged initiation of enteral feeding

  3. Myocardial Infarction [ Time Frame: 30 days ]
  4. Pneumonia [ Time Frame: 30 days ]
  5. Wound Infection [ Time Frame: 30 days ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01428050

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Contact: Harish Lavu, MD 215-955-9402 harish.lavu@jeffersonhospital.org

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United States, Pennsylvania
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Harish Lavu, MD    215-955-9402    Harish.Lavu@jeffersonhospital.org   
Sponsors and Collaborators
Thomas Jefferson University
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Principal Investigator: Harish Lavu, MD Thomas Jefferson University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01428050    
Other Study ID Numbers: Jefferson Hypertonic
First Posted: September 2, 2011    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015
Keywords provided by Thomas Jefferson University:
hypertonic saline
fluid restriction
resuscitation strategy
Additional relevant MeSH terms:
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