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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Pancreatic Cancer

Treatments: Other: Liberal perioperative fluid management; Other: restrictive perioperative fluid management

Study type: Interventional

Funder types: Other

Identifiers

NCT01058746

09-185

Details and patient eligibility

About

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.

Enrollment: 331 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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331 participants in 2 patient groups

pts undergoing pancreatic resection Restrictive arm

Active Comparator group

Description:

All patients will receive Normosol or equivalent solution, 0.5 ml/kg/fasted hour IV (approximately from 8am to time of induction) during induction of anesthesia. All patients will then receive maintenance fluids consisting of Normosol or equivalent solution at 6 ml/kg/operative hour. After randomization occurs, those patients randomized to the Restricted Arm will continue to receive Normosol or equivalent solution at 6ml/kg/operative hour.

Treatment:

Other: restrictive perioperative fluid management

pts undergoing pancreatic resection Liberal arm

Active Comparator group

Description:

All patients will receive Normosol or equivalent solution, 0.5 ml/kg/fasted hour IV (approximately from midnight to time of induction) during induction of anesthesia. All patients will then receive maintenance fluids consisting of Normosol or equivalent solution at 6 ml/kg/operative hour. Those patients randomized to the Liberal Arm will receive an additional Normosol bolus or equivalent solution equal to (another) 1.5 ml/kg/fasted hour IV (to bring the total to 2 ml/kg/fasted hour) plus an additional bolus of Normosol or equivalent solution 6ml/kg/operative hour to bring the hourly rate to 12ml/kg/operative hour with a maximum of 1000 ml/operative hour.

Treatment:

Other: Liberal perioperative fluid management