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A Prospective Randomized Controlled Clinical Trial of Restrictive Versus Liberal Perioperative Fluid Management for Patients Undergoing Pancreatic Resection


N/A
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

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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 CenterNew York, New York  10021