NCT01428050

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
264

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2011

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 18, 2015

Status Verified

March 1, 2015

Enrollment Period

4.1 years

First QC Date

August 31, 2011

Last Update Submit

March 17, 2015

Conditions

Pancreaticoduodenectomy

Keywords

whipplehypertonic salinepancreaticoduodenectomyfluid restrictionresuscitation strategy

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (2)

3% saline

EXPERIMENTAL

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

Lactated Ringers

ACTIVE COMPARATOR

15cc/kg/hr of lactated ringers solution intraoperatively

Drug: Lactated Ringers Solution

Interventions

3% NaCl SolutionDRUG

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

3% saline
Lactated Ringers SolutionDRUG

15cc/kg/hr for intraoperative fluids

Lactated Ringers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Related Publications (1)

  • Lavu H, Sell NM, Carter TI, Winter JM, Maguire DP, Gratch DM, Berman RA, Feil MG, Grunwald Z, Leiby BE, Pequignot EC, Rosato EL, Yeo CJ. The HYSLAR trial: a prospective randomized controlled trial of the use of a restrictive fluid regimen with 3% hypertonic saline versus lactated Ringers in patients undergoing pancreaticoduodenectomy. Ann Surg. 2014 Sep;260(3):445-53; discussion 453-5. doi: 10.1097/SLA.0000000000000872.

    PMID: 25115420DERIVED

MeSH Terms

Interventions

Ringer's Lactate

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Harish Lavu, MD

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Harish Lavu, MD

CONTACT

215-955-9402harish.lavu@jeffersonhospital.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2011

First Posted

September 2, 2011

Study Start

May 1, 2011

Primary Completion

June 1, 2015

Study Completion

December 1, 2015

Last Updated

March 18, 2015

Record last verified: 2015-03

Locations

US(1)