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

Phase 3

Completed

• Conditions: Liver Cancer
• Interventions: Procedure: Standard fluid management; Device: Goal directed fluid therapy with the Edwards EV1000 system

• Registration Number: NCT01596283
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-30
• Study First Submitted QC: 2012-05-09
• Study First Posted: 2012-05-10
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Results First Submitted: 2017-05-02
• Results First Submitted QC: 2017-09-19
• Last Update Submitted: 2017-09-19
• Results First Posted: 2017-10-18
• Last Update Posted: 2017-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard fluid management	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.
Goal directed fluid therapy	Goal directed fluid therapy with the Edwards EV1000 system	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.

Primary Outcome Measures

Name	Time	Method
Postoperative Complications	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

Name	Time	Method
Total Volume of Fluid Used Postoperatively	Postoperatively for the total admission time, up to 8 days	Postoperative fluid volume
Total Volume of Fluid Used Perioperatively	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
Postoperative Length of Stay	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
Low Cardiac Output Time	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

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States