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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Thomas Jefferson University
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01428050
First received: August 31, 2011
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Pancreaticoduodenectomy
Drug: 3% NaCl Solution
Drug: Lactated Ringers Solution
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Anastomotic Leak [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Leak or defect of gastrointestinal anastomosis including but not limited to pancreaticojejunostomy

  • Delayed Gastric Emptying [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Rate of delayed gastric emptying post procedure, prolonged initiation of enteral feeding

  • Myocardial Infarction [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Pneumonia [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Wound Infection [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 264
Study Start Date: May 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01428050

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

Locations
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
Investigators
Principal Investigator: Harish Lavu, MD Thomas Jefferson University
  More Information

No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01428050     History of Changes
Other Study ID Numbers: Jefferson Hypertonic
Study First Received: August 31, 2011
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:
whipple
hypertonic saline
pancreaticoduodenectomy
fluid restriction
resuscitation strategy

Additional relevant MeSH terms:
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014