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NCT Number: NCT01596283

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

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.

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Key information

Conditions

Liver Cancer Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard fluid management

Procedure

The patient will receive 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.

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. Total Volume of Fluid Used Postoperatively

    Time frame: Postoperatively for the total admission time, up to 8 days

    Postoperative fluid volume

  4. 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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

A Prospective Randomized Controlled Clinical Trial of Standard Compared to Goal-directed Perioperative Fluid Management (GDT) for Patients Undergoing Liver Resection

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
May 10, 2012
Registry last updated
Oct 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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