Trial Information

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

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.