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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01058746
• Other study ID #: 09-185
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: September 2019

Study information

• Verified date: September 2019
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 331
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer

Intervention

Other:
• restrictive perioperative fluid management
Normosol or equivalent solution 0.5 ml/kg/fasted hour IV (8am to time of induction) during induction of Anesthesia. Maintenance IV Normosol or equivalent solution at 6 ml/kg/operative hour. Blood loss to be replaced volume: volume with colloid until transfusion criteria met. Additional fluid boluses of 100ml Normosol or equivalent solution or bolus pressors (phenylephrine 40mcg or ephedrine 5mg) at the discretion of the Anesthesiologist to maintain patient hemodynamic stability.
• Liberal perioperative fluid management
Normosol or equivalent solution 0.5 ml/kg/fasted hr IV (8am to time of induction) of Anesthesia. Maintenance IV Normosol or equiv solution at 6 ml/kg/oper hr. At randomiz to the Liberal arm in the OR, an addit bolus of Normosol or equiv solution 1.5 ml/kg/fasted hr IV (8am to time of induction) will be given to bring the total to Normosol or equiv solution 2ml/kg/fasted hr IV (8am to time of induction). Pt will get an addit bolus of Normosol or equivalent solution 6ml/kg/oper hr. Maintenance IV Normosol or equivalent solution will then commence at 12ml/kg/operative hr with maximum of 1000 ml/operative hr. Blood loss replaced volume: with colloid, until transfusion criteria met (Additional fluid boluses of 100ml Normosol or equivalent solution or bolus pressors (phenylephrine 40mcg or ephedrine 5mg) used at the discretion of the Anes to maintain pt hemodynamic stability. Addit fluid boluses of 250ml Normosol or equivalent solution for urine output less than 1ml/kg for 2 hrs.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		3 years
Secondary	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.		3 years

External Links

•   Memorial Sloan Kettering Cancer Center