Randomized Trial of Restrictive Versus Liberal Perioperative Fluid Management for Patients Undergoing Pancreatic Resection

Completed · Not applicable

Conditions studied: Pancreatic Cancer

In brief

The purpose of this study is to help us learn what the best amount of fluid is that patients should receive during pancreas surgery. Patients will receive either the liberal fluid amount for this surgery or a restricted fluid amount. Both amounts of fluid have been used safely in patients having similar surgeries. These amounts have not been compared in pancreatic surgery. The fluids regimens that will be given are not experimental. This study will compare patients in the liberal and restricted fluid groups in terms of the nature of any surgical complications (problems)and recovery from surgery, including length of hospital stay.

Key facts

Study ID

NCT01058746

Run by

Memorial Sloan Kettering Cancer Center

People needed

331

Starts

2010-01-01

Expected to finish

2019-09-01

Last updated by the study team

2019-09-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults > or = 18 years
• Patients scheduled for Pancreaticoduodenectomy, Central Pancreatectomy or Distal Pancreatectomy.

You may not qualify if…

• 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 > 35
• American Society of Anesthesiologists Status > III, assigned at time of preoperative visit
• Corticosteroid use > 10 mg Prednisone/day
• Bilirubin > 10.0

Where it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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