A Prospective Randomized Controlled Clinical Trial of Standard Compared to Goal-directed Perioperative Fluid Management (GDT) for Patients Undergoing Liver Resection
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Liver Cancer
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 135
- Locations
- 1
- Primary Endpoint
- Postoperative Complications
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to help us learn what is the best amount of fluid to administer to patients during liver surgery. Patients will receive either an amount for this surgery based on weight, blood pressure, heart rate and urine output or an amount guided by a computerized system (FloTrac) that helps doctors know how much fluid each patient needs. The FloTrac calculates the amount of fluid patients needs on a minute-to-minute basis, based on real time information like blood pressure, pulse and the ability of the heart and blood vessels to maintain normal vital signs.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults (18 years old or greater) who are able to provide informed consent.
- •Patients who undergo an open, elective liver resection. Including those initially approached laparoscopically but converted to an open resection and those undergoing additional procedures.
Exclusion Criteria
- •Active coronary disease.
- •Patients with a history of coronary disease will be eligible if they have had a cardiac stress study showing no reversible ischemia and normal LV function within 3 months of operation.
- •Active symptomatic cerebrovascular disease.
- •Active congestive heart failure and ejection fraction \<35%.
- •Active severe restrictive or obstructive pulmonary disease and resting SpO2 \<90%.
- •Active renal dysfunction (Cr \>1.8)
- •Abnormal coagulation parameters (INR \> 1.8 not on Coumadin, or platelet count \< 100,000 per mcL)
- •Presence of active infection including HIV
- •Patients with active atrial fibrillation or flutter.
- •Preoperative hypoalbuminemia (Albumin \< 2g/dl).
Outcomes
Primary Outcomes
Postoperative Complications
Time Frame: 30 days post procedure
The incidence of overall 30-day postoperative complications will be recorded. These are defined in the MSKCC Adverse Events Program and organized by categories reflecting organ systems and further subdivided into specific complications within those and graded.
Secondary Outcomes
- Total Volume of Fluid Used Postoperatively(Postoperatively for the total admission time, up to 8 days)
- Total Volume of Fluid Used Perioperatively(Up to the first 72 hours postoperatively)
- Postoperative Length of Stay(Postoperatively for the total admission time, up to 8 days)
- Low Cardiac Output Time(Up to the first 24 postoperative hours)