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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Edwards Lifesciences |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00526331 |
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 |
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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 |
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 |
Estimated Enrollment: | 218 |
Study Start Date: | August 2007 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Study Group (FloTrac Sensor + Vigileo Monitor)
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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.
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2: Experimental
Control Group (FloTrac Sensor + Vigileo Monitor)
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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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Gabriel Mena, MD | U.T.M.D. Anderson Cancer Center |
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 |
Perioperative Therapy Perioperative Hydration Arterial Pressure Based Cardiac Output Vigileo Monitor |
FloTrac Sensor Fluid Volume APCO |
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 |
Neoplasms Neoplasms by Site |