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

NCT00526331 | Completed Phase 4 Results DMC

• 1 other identifier: 2007-0231
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Diseases; Gastrointestinal Diseases; Disorder of the Genitourinary System; Gynecologic Diseases; Kidney Diseases; Liver Diseases; Pancreatic Diseases; Prostate Cancer; Spinal Disease

Keywords

Perioperative Therapy; Perioperative Hydration; Arterial Pressure Based Cardiac Output; Vigileo Monitor; FloTrac Sensor; Fluid Volume; APCO

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Study Group

EXPERIMENTAL

FloTrac Sensor + Vigileo Monitor used to decide how much fluid to give during surgery.

Device: Vigileo Monitor; Device: FloTrac Sensor

Control Group

EXPERIMENTAL

FloTrac Sensor + Vigileo Monitor only used for data collection during surgery; Standard of Care to decide fluid amount.

Device: Vigileo Monitor; Device: FloTrac Sensor

Interventions

Vigileo Monitor DEVICE

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.

Control Group; Study Group

FloTrac Sensor DEVICE

Device connected to the patient's arterial line and Vigileo monitor that measures fluid requirements during surgery.

Control Group; Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is in hospital for study indicated treatment.
• Patient is able to comply with the study procedure.
• Patient must require an indwelling radial or a femoral artery catheter.
• Patients with an American Society of Anesthesiologists Risk Score \>= 3.
• Lee Risk Index \>/= 2 (Hypertension and Pre-diabetic metabolic state).
• Patient must be 40 kg or heavier.
• Patient has consented to be in the trial.
• Patient's height and weight can be accurately obtained prior to study start.
• Patient's ability to undergo major surgery with an anticipated blood loss \> 500 ml.

You may not qualify if:

• Patients with contraindications for the placement of radial, femoral, or other arterial cannula.
• Patients with contraindications for the placement of central venous cannula.
• Patients being treated with an intra-aortic balloon pump.
• Patients with aortic valve regurgitation.
• Patients with atrial fibrillation.
• Female patients with a known pregnancy confirmed by urine pregnancy test.
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Edwards Lifesciences: collaborator

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Esophageal Diseases; Gastrointestinal Diseases; Urogenital Diseases; Genital Diseases, Female; Kidney Diseases; Liver Diseases; Pancreatic Diseases; Prostatic Neoplasms; Spinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases; Urologic Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Gabriel Mena, MD / Professor
• Organization: UT MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Gabriel Mena, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2007
• First Posted: September 10, 2007
• Study Start: August 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: January 16, 2012
• Results First Posted: January 16, 2012

Record last verified: 2011-12

Locations

US (1)