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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01428050
Other study ID # Jefferson Hypertonic
Secondary ID
Status Recruiting
Phase Phase 2
First received August 31, 2011
Last updated March 17, 2015
Start date May 2011
Est. completion date December 2015

Study information

Verified date March 2015
Source Thomas Jefferson University
Contact Harish Lavu, MD
Phone 215-955-9402
Email harish.lavu@jeffersonhospital.org
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 264
Est. completion date December 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
3% NaCl Solution
1cc/kg/hr of 3%NaCl + 9cc/kg/hr of lactated ringers solution
Lactated Ringers Solution
15cc/kg/hr for intraoperative fluids

Locations

Country Name City State
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anastomotic Leak Leak or defect of gastrointestinal anastomosis including but not limited to pancreaticojejunostomy 30 days No
Primary Delayed Gastric Emptying Rate of delayed gastric emptying post procedure, prolonged initiation of enteral feeding 30 days No
Primary Myocardial Infarction 30 days Yes
Primary Pneumonia 30 days No
Primary Wound Infection 30 days No
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