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Hemodynamic Assessment APCO Monitor vs Crit Line for Renal Replacement Rx (APCOvC-Line)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00666003
First Posted: April 24, 2008
Last Update Posted: February 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Baystate Medical Center
  Purpose
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.

Condition
Renal Failure Hemodynamics

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hemodynamic Assessment Comparison Between Arterial Pressure Cardiac Output Monitor and Crit Line Utilized During Renal Replacement Therapy

Further study details as provided by Baystate Medical Center:

Enrollment: 26
Study Start Date: April 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Renal Failure Patients in the ICU
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00666003


Locations
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
Sponsors and Collaborators
Baystate Medical Center
Investigators
Principal Investigator: Patrick Mailloux, D.O. Baystate Medical Center
  More Information

Responsible Party: Patrick T. Mailloux, DO, Baystate Medical Cetner
ClinicalTrials.gov Identifier: NCT00666003     History of Changes
Other Study ID Numbers: IRB07-120
First Submitted: April 23, 2008
First Posted: April 24, 2008
Last Update Posted: February 8, 2011
Last Verified: February 2011

Keywords provided by Baystate Medical Center:
Hemodynamics

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases