Trial Information
A Prospective Randomized Controlled Clinical Trial of Restrictive Versus Liberal Perioperative Fluid Management for Patients Undergoing Pancreatic Resection
Inclusion Criteria:
- Adults > or = 18 years
- Patients scheduled for Pancreaticoduodenectomy, Central Pancreatectomy or Distal
Pancreatectomy.
Exclusion Criteria:
- Pregnancy
- History of active coronary disease unless a cardiac stress test showing no reversible
ischemia and normal LV function within 30 days of operation
- MI within 3 months
- History of stroke
- History of congestive heart failure and ejection fraction less than 35%
- History of severe COPD and resting oxygen saturation (SpO2) < 90%
- Renal dysfunction (Cr > 1.8)
- Abnormal coagulation parameters (INR > 1.5 not on Coumadin, or platelet
Presence of active infection including HIV
- BMI > 40
- American Society of Anesthesiologists Status > III, assigned at time of pre operative
visit
- Corticosteroid use > 10 mg Prednisone/day
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine if restrictive perioperative fluid management results in fewer complications, morbidity and decreased length of stay in patients undergoing pancreatic resection, compared to liberal fluid management.
Outcome Time Frame:
3 years
Safety Issue:
Yes
Principal Investigator
Florence Grant, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
09-185
NCT ID:
NCT01058746
Start Date:
January 2010
Completion Date:
January 2014
Related Keywords:
- Pancreatic Cancer
- pancreas
- surgery
- Pancreaticoduodenectomy
- Central Pancreatectomy
- Distal Pancreatectomy
- resection
- IV fluids
- 09-185
- Pancreatic Neoplasms
Name | Location |
Memorial Sloan Kettering Cancer Center |
New York, New York 10021 |