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

December 8, 2011 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

THE EDWARDS VIGILEO MONITOR:

The Vigileo™ monitor measures the amount of blood the heart pumps through the body.

SCREENING TEST:

Before you can begin this study, you will have a "screening test" to help the doctor decide if you are eligible to take part in this study. Women who are able to have children must have a negative urine pregnancy test.

STUDY GROUP:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to either the Control Group or the Study Group. You will have an equal chance of being assigned to either group. You will not know to which group you have been assigned.

STUDY PARTICIPATION:

You will have a arterial catheter (small plastic tube) inserted into an artery inside your wrist at the beginning of surgery. This is used routinely (even in patients not taking part in the study) to measure your blood pressure more accurately rather than with a blood pressure cuff. It is inserted after you receive general anesthesia (numbing medicine), so you should feel no pain. If it is inserted while you are awake (based on the judgment of your anesthesiologist), then local anesthesia will be given to you to reduce discomfort.

If your doctors decide that an arterial catheter is not required as part of your routine medical care during your surgery, they will not place one for study purposes only. In that situation, you will be removed from the study, and your medical care will continue as planned by your doctors.

If the catheter is placed, the Vigileo™ monitor will be connected to the catheter and readings will be taken during the surgery. It will be disconnected at the end of surgery.

If you are in the Study Group, your doctor will use the monitor and routine vital sign measurement to decide how much fluid to give you during surgery.

If you are in the Control Group, your doctor will not know the information being collected by the monitor, as it will be collected and compared to the information collected from participants in the Study Group. The amount of fluid you received during surgery will be decided by routine vital sign measurement, as is standard of care.

ESOPHAGEAL DOPPLER:

Regardless of study group assignment, during your surgery, researchers will also connect an esophageal doppler which will also collect data on fluid volume.

The esophageal doppler is a thin, tube-like device that is placed in your throat while you are asleep. This is used routinely by doctors to assist in the administration of fluids during surgery.

The information from the doppler will be compared to the information collected from the Vigileo™ monitor. The esophageal doppler measures blood flow through your heart by ultrasound waves.

LENGTH OF STUDY:

You will be considered off study once you leave the recovery room.

FOLLOW-UP:

Researchers will be collecting information on your progress during and after surgery, including when you are allowed to leave the hospital. Your medical records will be reviewed after surgery and up to 6 months after surgery to see how you are doing and if you have had any medical problems. The kind of information researchers will be collecting is the amount of time you were in the intensive care (if any), amount of time in the hospital, any complications or problems you may have had, how well you organs are functioning, and general health information.

This is an investigational study. The Vigileo™ Monitor and esophageal doppler are FDA approved and commercially available for volume monitoring. The comparison of the monitor and doppler is investigational.

Up to 218 patients will be enrolled in this multi-center study. Up to 66 will be enrolled at M.D. Anderson.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • U.T.M.D. Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient is in hospital for study indicated treatment.
  2. Patient is able to comply with the study procedure.
  3. Patient must require an indwelling radial or a femoral artery catheter.
  4. Patients with an American Society of Anesthesiologists Risk Score >= 3.
  5. Lee Risk Index >/= 2 (Hypertension and Pre-diabetic metabolic state).
  6. Patient must be 40 kg or heavier.
  7. Patient has consented to be in the trial.
  8. Patient's height and weight can be accurately obtained prior to study start.
  9. Patient's ability to undergo major surgery with an anticipated blood loss > 500 ml.

Exclusion Criteria:

  1. Patients with contraindications for the placement of radial, femoral, or other arterial cannula.
  2. Patients with contraindications for the placement of central venous cannula.
  3. Patients being treated with an intra-aortic balloon pump.
  4. Patients with aortic valve regurgitation.
  5. Patients with atrial fibrillation.
  6. Female patients with a known pregnancy confirmed by urine pregnancy test.
  7. Patient is currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the study endpoints.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group
FloTrac Sensor + Vigileo Monitor used to decide how much fluid to give during surgery.
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.
Experimental: Control Group
FloTrac Sensor + Vigileo Monitor only used for data collection during surgery; Standard of Care to decide fluid amount.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Hospital Stay (LOS) by Participant
Time Frame: From baseline (first day of hospital stay) to release from hospital (anticipate 5 days minimally)
Length of hospital stay of arterial pressure-based cardiac output (APCO) monitor participants versus the participants using the global standard care guided by esophageal Doppler, measured in days.
From baseline (first day of hospital stay) to release from hospital (anticipate 5 days minimally)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

Edwards Lifesciences

Investigators

  • Principal Investigator: Gabriel Mena, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

September 5, 2007

First Submitted That Met QC Criteria

September 5, 2007

First Posted (Estimate)

September 10, 2007

Study Record Updates

Last Update Posted (Estimate)

January 16, 2012

Last Update Submitted That Met QC Criteria

December 8, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-0231

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Liver Diseases

Clinical Trials on Vigileo Monitor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe