Back to resultsClinical Trial of Standard Versus Goal-Directed Perioperative Fluid Management (GDT) for Patients Undergoing Liver Resection
Primary Purpose
Liver Cancer
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Standard fluid management
Goal directed fluid therapy with the Edwards EV1000 system
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cancer focused on measuring Perioperative Fluid Management, liver resection, 12-056
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
Sites / Locations
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Standard fluid management
Goal directed fluid therapy
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Low Cardiac Output Time
Assess the impact of GDT compared to standard fluid therapy on the total time patients experience low cardiac output perioperatively
Total Volume of Fluid Used Perioperatively
Assess the impact of GDT compared to standard fluid therapy on the total volume of fluid given intraoperatively
Total Volume of Fluid Used Postoperatively
Postoperative fluid volume
Postoperative Length of Stay
Assess the impact of GDT compared to standard fluid therapy on net fluid balance for the total admission time
Full Information
NCT ID
NCT01596283
First Posted
April 30, 2012
Last Updated
September 19, 2017
Sponsor
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT01596283
Brief Title
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
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
Perioperative Fluid Management, liver resection, 12-056
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard fluid management
Arm Type
Active Comparator
Arm 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.
Arm Title
Goal directed fluid therapy
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Standard fluid management
Intervention Description
The patient will receive standard fluid management
Intervention Type
Device
Intervention Name(s)
Goal directed fluid therapy with the Edwards EV1000 system
Intervention Description
This arm will have fluid therapy guided by the Edwards EV1000 system.
Primary Outcome Measure Information:
Title
Postoperative Complications
Description
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.
Time Frame
30 days post procedure
Secondary Outcome Measure Information:
Title
Low Cardiac Output Time
Description
Assess the impact of GDT compared to standard fluid therapy on the total time patients experience low cardiac output perioperatively
Time Frame
Up to the first 24 postoperative hours
Title
Total Volume of Fluid Used Perioperatively
Description
Assess the impact of GDT compared to standard fluid therapy on the total volume of fluid given intraoperatively
Time Frame
Up to the first 72 hours postoperatively
Title
Total Volume of Fluid Used Postoperatively
Description
Postoperative fluid volume
Time Frame
Postoperatively for the total admission time, up to 8 days
Title
Postoperative Length of Stay
Description
Assess the impact of GDT compared to standard fluid therapy on net fluid balance for the total admission time
Time Frame
Postoperatively for the total admission time, up to 8 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Fischer, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26206652
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.
Results Reference
derived
Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
Clinical Trial of Standard Versus Goal-Directed Perioperative Fluid Management (GDT) for Patients Undergoing Liver Resection
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