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

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.

Study Overview

• Status: Completed
• Conditions: Liver Cancer
• Intervention / Treatment: Procedure: Standard fluid management; Device: Goal directed fluid therapy with the Edwards EV1000 system

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard fluid management; 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; The patient will receive standard fluid management
Active Comparator: Goal directed fluid therapy; 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; This arm will have fluid therapy guided by the Edwards EV1000 system.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Mary Fischer, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

General Publications

• 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.

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: April 30, 2012
• First Submitted That Met QC Criteria: May 9, 2012
• First Posted (Estimate): May 10, 2012

Study Record Updates

• Last Update Posted (Actual): October 18, 2017
• Last Update Submitted That Met QC Criteria: September 19, 2017
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Perioperative Fluid Management; liver resection; 12-056
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: 12-056