Randomized Trial of Restrictive Versus Liberal Perioperative Fluid Management for Patients Undergoing Pancreatic Resection - Full Text View

Purpose

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.

Condition	Intervention
Pancreatic Cancer	Other: restrictive perioperative fluid management Other: Liberal perioperative fluid management

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Prospective Randomized Controlled Clinical Trial of Restrictive Versus Liberal Perioperative Fluid Management for Patients Undergoing Pancreatic Resection

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 pts getting pancreatic resection. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	330
Study Start Date:	January 2010
Estimated Study Completion Date:	January 2014
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: pts undergoing pancreatic resection Restrictive arm 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.	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.
Active Comparator: pts undergoing pancreatic resection Liberal arm 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.	Other: Liberal 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 equiv solution at 6 ml/kg/oper hour. 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). Then the pt will receive an addit bolus of Normosol or equivalent solution 6ml/kg/oper hour. Maintenance IV Normosol or equivalent solution will then commence at 12ml/kg/operative hour. Blood loss 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) 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 hours.

Arms

Assigned Interventions

Active Comparator: pts undergoing pancreatic resection Restrictive arm

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.

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.

Active Comparator: pts undergoing pancreatic resection Liberal arm

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.

Other: Liberal 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 equiv solution at 6 ml/kg/oper hour. 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). Then the pt will receive an addit bolus of Normosol or equivalent solution 6ml/kg/oper hour. Maintenance IV Normosol or equivalent solution will then commence at 12ml/kg/operative hour. Blood loss 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) 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 hours.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01058746

Contacts

Contact: Florence Grant, MD	212-639-8829
Contact: Murray Brennan, MD

Locations

United States, New York
Memorial Sloan Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Florence Grant, MD 212-639-8829
Contact: Murray Brennan, MD
Principal Investigator: Florence Grant, MD

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Florence Grant, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT01058746 History of Changes
Other Study ID Numbers:	09-185
Study First Received:	January 27, 2010
Last Updated:	May 21, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

pancreas
surgery
Pancreaticoduodenectomy
Central Pancreatectomy

Distal Pancreatectomy
resection
IV fluids
09-185

Additional relevant MeSH terms:

Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms

Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 21, 2013