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Evaluation of Arterial Pressure Based Cardiac Output for Goal-Directed Perioperative Therapy
This study has been completed.
Sponsors and Collaborators: M.D. Anderson Cancer Center
Edwards Lifesciences
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00526331
  Purpose

Primary Objective:

-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.


Condition Intervention Phase
Esophageal Diseases
Gastrointestinal Diseases
Genitourinary Diseases
Gynecologic Diseases
Kidney Diseases
Liver Diseases
Pancreatic Diseases
Prostate Cancer
Spinal Disease
Device: Vigileo Monitor
Device: FloTrac Sensor
Phase IV

MedlinePlus related topics: Cancer Esophagus Disorders Liver Diseases Pancreatic Diseases Prostate Cancer Reproductive Health Spinal Diseases
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Official Title: Randomized Evaluation of Arterial Pressure Based Cardiac Output for Goal-Directed Perioperative Therapy

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To learn if the Edwards Vigileo™ monitor can measure a patients fluid volume, in addition to measuring vital signs (blood pressure, pulse, temperature, and breathing rate), as well as current methods. [ Time Frame: September 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The long-term outcomes after surgery will also be measured. [ Time Frame: September 2008 ] [ Designated as safety issue: No ]

Estimated Enrollment: 218
Study Start Date: August 2007
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Study Group (FloTrac Sensor + Vigileo Monitor)
Device: Vigileo Monitor
Arm 1 = The monitor and routine vital sign measurements will be used to decide how much fluid to give during surgery; Arm 2 = Information from the monitor will be collected and compared to the information collected from participants in Arm 1.
Device: FloTrac Sensor
Device connected to the patient's arterial line and Vigileo monitor that measures fluid requirements during surgery.
2: Experimental
Control Group (FloTrac Sensor + Vigileo Monitor)
Device: Vigileo Monitor
Arm 1 = The monitor and routine vital sign measurements will be used to decide how much fluid to give during surgery; Arm 2 = Information from the monitor will be collected and compared to the information collected from participants in Arm 1.
Device: FloTrac Sensor
Device connected to the patient's arterial line and Vigileo monitor that measures fluid requirements during surgery.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00526331

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27708
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
United Kingdom
University College
London, United Kingdom
Sponsors and Collaborators
M.D. Anderson Cancer Center
Edwards Lifesciences
Investigators
Principal Investigator: Gabriel Mena, MD U.T.M.D. Anderson Cancer Center
  More Information

MD Anderson Cancer Center  This link exits the ClinicalTrials.gov site

Responsible Party: U.T.M.D. Anderson Cancer Center ( Gabriel Mena, MD/Assistant Professor )
Study ID Numbers: 2007-0231
Study First Received: September 5, 2007
Last Updated: October 21, 2008
ClinicalTrials.gov Identifier: NCT00526331  
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Perioperative Therapy
Perioperative Hydration
Arterial Pressure Based Cardiac Output
Vigileo Monitor
FloTrac Sensor
Fluid Volume
APCO

Study placed in the following topic categories:
Spinal Diseases
Liver Diseases
Esophageal disorder
Prostatic Diseases
Genital Neoplasms, Male
Gastrointestinal Diseases
Urogenital Neoplasms
Genital Diseases, Male
Bone Diseases
Genital Diseases, Female
Digestive System Diseases
Musculoskeletal Diseases
Urologic Diseases
Pancreatic Diseases
Esophageal Diseases
Kidney Diseases
Prostatic Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009