Prostate Cancer Clinical Trial
Official title:
Randomized Evaluation of Arterial Pressure Based Cardiac Output for Goal-Directed Perioperative Therapy
Verified date | December 2011 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 49 |
Est. completion date | September 2008 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | U.T.M.D. Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | Edwards Lifesciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Length of Hospital Stay (LOS) by Participant | 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. | From baseline (first day of hospital stay) to release from hospital (anticipate 5 days minimally) | No |
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