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Evaluation of Arterial Pressure Based Cardiac Output for Goal-Directed Perioperative Therapy

NCT00526331 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2012-01-16

Study results available
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Summary

The purpose of this study is to determine whether the early identification and more precise intervention of operating room (OR) patient fluid administration optimization using arterial pressure-based cardiac output (APCO) yields comparable patient outcome as fluid administration optimization using a global standard care method.

Conditions

Interventions

DEVICE

Vigileo Monitor

Study Group = The monitor and routine vital sign measurements will be used to decide how much fluid to give during surgery; Control Group = Information from the monitor will be collected and compared to the information collected from participants in Study Group.

DEVICE

FloTrac Sensor

Device connected to the patient's arterial line and Vigileo monitor that measures fluid requirements during surgery.

Sponsors & Collaborators

  • Edwards Lifesciences

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Gabriel Mena, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00526331 on ClinicalTrials.gov