Clinical Trial of Standard Versus Goal-Directed Perioperative Fluid Management (GDT) for Patients Undergoing Liver Resection

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Randomized Controlled Clinical Trial of Standard Compared to Goal-directed Perioperative Fluid Management (GDT) for Patients Undergoing Liver Resection

Conditions
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Liver Cancer

Intervention / Treatment
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* Procedure: Standard fluid management
* Device: Goal directed fluid therapy with the Edwards EV1000 system


Participation Criteria
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Eligibility Criteria
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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). Female patients who are pregnant (female patients of child-bearing potential must have a negative serum pregnancy test ≤ 14 days prior to surgery or 15 to 30 days prior to surgery with a negative urine pregnancy test the morning of surgery). Presence of ascites. BMI > 45 or <17

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard fluid management<br>Prospective single-blinded randomized trial. Eligible patients will be consented for the trial prior to surgery. However randomization will not occur until the operating room. After the liver has been resected, intraoperative randomization will be done by envelopes. | Procedure: Standard fluid management<br>* The patient will receive standard fluid management<br>|
| Active Comparator: Goal directed fluid therapy<br>Prospective single-blinded randomized trial. Eligible patients will be consented for the trial prior to surgery. However randomization will not occur until the operating room. After the liver has been resected, intraoperative randomization will be done by envelopes. | Device: Goal directed fluid therapy with the Edwards EV1000 system<br>* This arm will have fluid therapy guided by the Edwards EV1000 system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Complications | 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. | 30 days post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low Cardiac Output Time | Assess the impact of GDT compared to standard fluid therapy on the total time patients experience low cardiac output perioperatively | Up to the first 24 postoperative hours | 
| Total Volume of Fluid Used Perioperatively | Assess the impact of GDT compared to standard fluid therapy on the total volume of fluid given intraoperatively | Up to the first 72 hours postoperatively | 
| Total Volume of Fluid Used Postoperatively | Postoperative fluid volume | Postoperatively for the total admission time, up to 8 days | 
| Postoperative Length of Stay | Assess the impact of GDT compared to standard fluid therapy on net fluid balance for the total admission time | Postoperatively for the total admission time, up to 8 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perioperative Fluid Management, liver resection, 12-056