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

This study has been completed.
Sponsor:
Collaborator:
Edwards Lifesciences
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00526331
First received: September 5, 2007
Last updated: December 8, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Esophageal Diseases
Gastrointestinal Diseases
Disorder of the Genitourinary System
Gynecologic Diseases
Kidney Diseases
Liver Diseases
Pancreatic Diseases
Prostate Cancer
Spinal Disease
Device: Vigileo Monitor
Device: FloTrac Sensor
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Evaluation of Arterial Pressure Based Cardiac Output for Goal-Directed Perioperative Therapy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Length of Hospital Stay (LOS) by Participant [ Time Frame: From baseline (first day of hospital stay) to release from hospital (anticipate 5 days minimally) ] [ Designated as safety issue: No ]
    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.


Enrollment: 49
Study Start Date: August 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Edwards Lifesciences
Investigators
Principal Investigator: Gabriel Mena, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00526331     History of Changes
Other Study ID Numbers: 2007-0231
Study First Received: September 5, 2007
Results First Received: December 8, 2011
Last Updated: December 8, 2011
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

Additional relevant MeSH terms:
Genital Diseases, Female
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Kidney Diseases
Liver Diseases
Pancreatic Diseases
Prostatic Neoplasms
Spinal Diseases
Urologic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 28, 2014