Trial Outcomes & Findings for Evaluation of Arterial Pressure Based Cardiac Output for Goal-Directed Perioperative Therapy (NCT NCT00526331)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

49 participants

Primary outcome timeframe

From baseline (first day of hospital stay) to release from hospital (anticipate 5 days minimally)

Results posted on

2012-01-16

Participant Flow

Recruitment Period of August 8, 2007 to June 30, 2008 at UT MD Anderson Cancer Center. Study recruitment done at medical clinics.

Study terminated by sponsor responsible for multi-center data collection and reporting. No data collection or analysis completed.

Participant milestones

Participant milestones
Measure	Overall Study Study Group: FloTrac Sensor + Vigileo Monitor used to decide how much fluid to give during surgery; and Control Group: FloTrac Sensor + Vigileo Monitor only used for data collection during surgery while Standard of Care used to decide fluid amount.
Overall Study STARTED	55
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	55

Reasons for withdrawal

Reasons for withdrawal
Measure	Overall Study Study Group: FloTrac Sensor + Vigileo Monitor used to decide how much fluid to give during surgery; and Control Group: FloTrac Sensor + Vigileo Monitor only used for data collection during surgery while Standard of Care used to decide fluid amount.
Overall Study Sponsor Termination	55

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=55 Participants Study Group: FloTrac Sensor + Vigileo Monitor used to decide how much fluid to give during surgery; and Control Group: FloTrac Sensor + Vigileo Monitor only used for data collection during surgery while Standard of Care used to decide fluid amount.
Age Continuous	62 years n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants
Region of Enrollment United States	55 participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline (first day of hospital stay) to release from hospital (anticipate 5 days minimally)

Population: Study terminated by sponsor without analysis due to technical reasons.

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.

Outcome measures

Outcome data not reported

Adverse Events

Overall Study

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gabriel Mena, MD / Professor

UT MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place