- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00666003
Hemodynamic Assessment APCO Monitor vs Crit Line for Renal Replacement Rx (APCOvC-Line)
February 7, 2011 updated by: Baystate Medical Center
Hemodynamic Assessment Comparison Between Arterial Pressure Cardiac Output Monitor and Crit Line Utilized During Renal Replacement Therapy
Fluid and volume management are a challenging part of critical care and the difficulties increase in the face of renal failure.
Utilizing the Crit-Line to monitor blood volume changes in conjunction with arterial pressure cardiac output monitoring may lead to better understanding of the impact fluid removal during dialysis has on hemodynamics.
Study Overview
Status
Completed
Conditions
Detailed Description
Patients in an ICU often require large amounts of IV fluid to maintain adequate cardiac function.
In patients with renal failure, the ability to gauge adequacy of circulating blood volume based on urine output is obviously lacking.
The FDA approved devices called Flotrac/Vigileo and Crit-Line are used in this setting to determine adequacy of fluid resuscitation.
This study proposes to use the data collected in a retrospective manner to determine if correlation of the various measured parameters can serve as a predictor of hemodynamic status.
Study Type
Observational
Enrollment (Actual)
26
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Springfield, Massachusetts, United States, 01199
- Baystate Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Renal Failure Patients in the ICU
Description
Inclusion Criteria:
- Indwelling arterial catheter
- Require dialysis
- CVP in place
- Use of Crit-Line and Flotrak device
Exclusion Criteria:
- Aortic Regurgitation
- Use of an intra-aortic balloon pump
- Weight less than 90 lbs
- Cardiac arrhythmias
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Patrick Mailloux, D.O., Baystate Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
April 23, 2008
First Submitted That Met QC Criteria
April 23, 2008
First Posted (Estimate)
April 24, 2008
Study Record Updates
Last Update Posted (Estimate)
February 8, 2011
Last Update Submitted That Met QC Criteria
February 7, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB07-120
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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