Clinical Trial of Standard Versus Goal-Directed Perioperative Fluid Management (GDT) for Patients Undergoing Liver Resection
NCT ID: NCT01596283
Last Updated: 2017-10-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
135 participants
INTERVENTIONAL
2012-04-30
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Standard fluid management
The patient will receive standard fluid management
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.
Goal directed fluid therapy with the Edwards EV1000 system
This arm will have fluid therapy guided by the Edwards EV1000 system.
Interventions
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Standard fluid management
The patient will receive standard fluid management
Goal directed fluid therapy with the Edwards EV1000 system
This arm will have fluid therapy guided by the Edwards EV1000 system.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Mary Fischer, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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12-056
Identifier Type: -
Identifier Source: org_study_id