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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01596283
First Posted: May 10, 2012
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
  Purpose
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.

Condition Intervention Phase
Liver Cancer Procedure: Standard fluid management Device: Goal directed fluid therapy with the Edwards EV1000 system Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled Clinical Trial of Standard Compared to Goal-directed Perioperative Fluid Management (GDT) for Patients Undergoing Liver Resection

Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • Postoperative Complications [ Time Frame: 30 days post procedure ]
    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 [ Time Frame: Up to the first 24 postoperative hours ]
    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 [ Time Frame: Up to the first 72 hours postoperatively ]
    Assess the impact of GDT compared to standard fluid therapy on the total volume of fluid given intraoperatively

  • Total Volume of Fluid Used Postoperatively [ Time Frame: Postoperatively for the total admission time, up to 8 days ]
    Postoperative fluid volume

  • Postoperative Length of Stay [ Time Frame: Postoperatively for the total admission time, up to 8 days ]
    Assess the impact of GDT compared to standard fluid therapy on net fluid balance for the total admission time


Enrollment: 135
Study Start Date: April 2012
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01596283


Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Mary Fischer, MD Memorial Sloan Kettering Cancer Center
  Study Documents (Full-Text)

Documents provided by Memorial Sloan Kettering Cancer Center:
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01596283     History of Changes
Other Study ID Numbers: 12-056
First Submitted: April 30, 2012
First Posted: May 10, 2012
Results First Submitted: May 2, 2017
Results First Posted: October 18, 2017
Last Update Posted: October 18, 2017
Last Verified: May 2016

Keywords provided by Memorial Sloan Kettering Cancer Center:
Perioperative Fluid Management
liver resection
12-056

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases