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

NCT01596283 | Completed Phase 3 Results

• 1 other identifier: 12-056
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer

Keywords

Perioperative Fluid Management; liver resection; 12-056

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Low Cardiac Output Time

  Up to the first 24 postoperative hours

• Total Volume of Fluid Used Perioperatively

  Up to the first 72 hours postoperatively

• Total Volume of Fluid Used Postoperatively

  Postoperatively for the total admission time, up to 8 days

• Postoperative Length of Stay

  Postoperatively for the total admission time, up to 8 days

Study Arms (2)

Standard fluid management

ACTIVE COMPARATOR

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

Goal directed fluid therapy

ACTIVE COMPARATOR

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

Interventions

Standard fluid management PROCEDURE

The patient will receive standard fluid management

Standard fluid management

Goal directed fluid therapy with the Edwards EV1000 system DEVICE

This arm will have fluid therapy guided by the Edwards EV1000 system.

Goal directed fluid therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

• 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.

  PMID: 26206652 DERIVED

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Results Point of Contact

• Title: Dr. Mary Fischer MD
• Organization: Memorial Sloan Kettering Cancer Center

fischerm@mskcc.org

212-639-6745

Study Officials

• Mary Fischer, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2012
• First Posted: May 10, 2012
• Study Start: April 1, 2012
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: October 18, 2017
• Results First Posted: October 18, 2017

Record last verified: 2016-05

Locations

US (1)