Restrictive or Liberal Fluid Management in Treating Patients Undergoing Pancreatic Surgery
This trial is active, not recruiting.
|Treatments||restrictive perioperative fluid management, liberal perioperative fluid management|
|Sponsor||Memorial Sloan Kettering Cancer Center|
|Start date||January 2010|
|End date||January 2017|
|Trial size||331 participants|
|Trial identifier||NCT01058746, 09-185|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
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.
time frame: 3 years
Determine if restrictive perioperative fluid management, comp to liberal periop fluid management, decreases delayed gastric emptying, length of stay (LOS) & the incidence of other, less frequent morbidity in adult patients getting pancreatic resection.
time frame: 3 years
Male or female participants at least 18 years old.
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 > 35 - American Society of Anesthesiologists Status > III, assigned at time of preoperative visit - Corticosteroid use > 10 mg Prednisone/day - Bilirubin > 10.0
|Official title||A Prospective Randomized Controlled Clinical Trial of Restrictive Versus Liberal Perioperative Fluid Management for Patients Undergoing Pancreatic Resection|
|Principal investigator||Florence Grant, MD|
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