Clinical trial NCT01596283: Clinical Trial of Standard Versus Goal-Directed Perioperative Fluid Management (GDT) for Patients Undergoing Liver Resection
Official title: A Prospective Randomized Controlled Clinical Trial of Standard Compared to Goal-directed Perioperative Fluid Management (GDT) for Patients Undergoing Liver Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Liver Cancer
Keywords: Perioperative Fluid Management
liver resection
12-056
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2012-05-10
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).
* 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

Primary outcomes:
measure: Postoperative Complications
timeFrame: 30 days post procedure
Secondary outcomes:
measure: Low Cardiac Output Time
timeFrame: Up to the first 24 postoperative hours
measure: Total Volume of Fluid Used Perioperatively
timeFrame: Up to the first 72 hours postoperatively
measure: Total Volume of Fluid Used Postoperatively
timeFrame: Postoperatively for the total admission time, up to 8 days
measure: Postoperative Length of Stay
timeFrame: Postoperatively for the total admission time, up to 8 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Mary Fischer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Correa-Gallego C, Tan KS, Arslan-Carlon V, Gonen M, Denis SC, Langdon-Embry L, Grant F, Kingham TP, DeMatteo RP, Allen PJ, D'Angelica MI, Jarnagin WR, Fischer M. Goal-Directed Fluid Therapy Using Stroke Volume Variation for Resuscitation after Low Central Venous Pressure-Assisted Liver Resection: A Randomized Clinical Trial. J Am Coll Surg. 2015 Aug;221(2):591-601. doi: 10.1016/j.jamcollsurg.2015.03.050. Epub 2015 Apr 7.