Randomized Trial of Restrictive Versus Liberal Perioperative Fluid Management for Patients Undergoing Pancreatic Resection
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Pancreatic Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/25/2019 |
| Start Date: | January 2010 |
| End Date: | January 2020 |
A Prospective Randomized Controlled Clinical Trial of Restrictive Versus Liberal Perioperative Fluid Management for Patients Undergoing Pancreatic Resection
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.
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.
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
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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