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



Status:Completed
Conditions:Liver Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/20/2017
Start Date:April 2012
End Date:May 2016

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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

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.


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
We found this trial at
1
site
1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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