Randomized Trial Of Restrictive Versus Liberal Perioperative Fluid Management For Patients Undergoing Pancreatic Resection

Study Overview

Randomized 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.

N/A

Pancreatic Cancer

OTHER: restrictive perioperative fluid management
OTHER: Liberal perioperative fluid management

09-185

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2010-01-27	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-09-24
First Submitted that Met QC Criteria 2010-01-27	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-09-25
First Posted (ACTUAL) 2010-01-29	Results First Posted N/A	Last Verified 2019-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
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 soluti	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 trans
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 s	OTHER: 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

Participant Group/Arm

Intervention/Treatment

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 soluti

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 trans

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 s

OTHER: 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

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Adults > or = 18 years
Patients scheduled for Pancreaticoduodenectomy, Central Pancreatectomy or Distal Pancreatectomy.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Florence Grant, MD, Memorial Sloan Kettering Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record