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

This study has been completed.
Sponsor:
Information provided by:
Baystate Medical Center
ClinicalTrials.gov Identifier:
NCT00666003
First received: April 23, 2008
Last updated: February 7, 2011
Last verified: February 2011
  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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Patrick T. Mailloux, DO, Baystate Medical Cetner
ClinicalTrials.gov Identifier: NCT00666003     History of Changes
Other Study ID Numbers: IRB07-120
Study First Received: April 23, 2008
Last Updated: February 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Baystate Medical Center:
Hemodynamics

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 26, 2014