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

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ClinicalTrials.gov Identifier: NCT00526331
Recruitment Status : Completed
First Posted : September 10, 2007
Results First Posted : January 16, 2012
Last Update Posted : January 16, 2012
Sponsor:
Collaborator:
Edwards Lifesciences
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Evaluation of Arterial Pressure Based Cardiac Output for Goal-Directed Perioperative Therapy
Study Start Date : August 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00526331


Locations
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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
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Principal Investigator: Gabriel Mena, MD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00526331    
Other Study ID Numbers: 2007-0231
First Posted: September 10, 2007    Key Record Dates
Results First Posted: January 16, 2012
Last Update Posted: January 16, 2012
Last Verified: December 2011
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:
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Spinal Diseases
Liver Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pancreatic Diseases
Esophageal Diseases
Kidney Diseases
Urologic Diseases
Bone Diseases
Musculoskeletal Diseases