Hemodynamic Assessment APCO Monitor vs Crit Line for Renal Replacement Rx

Renal Failure Clinical Trial

— APCOvC-Line  

Official title:

Hemodynamic Assessment Comparison Between Arterial Pressure Cardiac Output Monitor and Crit Line Utilized During Renal Replacement Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00666003
• Other study ID #: IRB07-120
• Status: Completed
• Phase: N/A
• First received: April 23, 2008
• Last updated: February 7, 2011
• Start date: April 2008
• Est. completion date: November 2009

Study information

• Verified date: February 2011
• Source: Baystate Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemodynamics
• Renal Failure

Locations

Country	Name	City	State
United States	Baystate Medical Center	Springfield	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Baystate Medical Center

Country where clinical trial is conducted

United States,