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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 3

Conditions: Liver Cancer

Treatments: Procedure: Standard fluid management; Device: Goal directed fluid therapy with the Edwards EV1000 system

Study type: Interventional

Funder types: Other

Identifiers

NCT01596283

12-056

Details and patient eligibility

About

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.

Enrollment: 135 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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135 participants in 2 patient groups

Standard fluid management

Active Comparator group

Description:

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.

Treatment:

Procedure: Standard fluid management

Goal directed fluid therapy

Active Comparator group

Description:

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.

Treatment:

Device: Goal directed fluid therapy with the Edwards EV1000 system