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

Completed · Phase 3

Conditions studied: Liver Cancer

In brief

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.

Key facts

Study ID

NCT01596283

Run by

Memorial Sloan Kettering Cancer Center

People needed

135

Starts

2012-04-01

Expected to finish

2016-05-01

Last updated by the study team

2017-10-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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