Peripheral Venous Oxygen Saturation and Biomarkers to Estimate Cardiac Output and Filling Pressures in Heart Failure

Congestive Heart Failure Clinical Trial

Official title:

Use of Peripheral Venous Oxygen Saturation and Biomarkers to Estimate Cardiac Output and Filling Pressures in Patients With Advanced Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00595738
• Other study ID #: 2007P-000704
• Status: Completed
• Phase: N/A
• First received: January 7, 2008
• Last updated: July 19, 2011
• Start date: December 2007
• Est. completion date: January 2011

Study information

• Verified date: July 2011
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The relationship between peripheral venous saturation and central hemodynamics (including right and left heart filling pressures and cardiac output), mixed venous oxygen saturation, and contemporary biomarkers of heart failure is not clear. We aim to determine the relationship between mixed venous, central venous, and peripheral venous oxygen saturation in patients with advanced (class III or IV) heart failure. We will determine the relationship between cardiac output measured via thermodilution and the Fick equation calculated using concurrent oxygen saturations from the distal PA, central vein, and peripheral vein. We also aim to examine the relationship of selected cardiac biomarkers with cardiac filling pressures and cardiac output over time in patients with decompensated heart failure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

The following inclusion criteria will be utilized:

1. Age>21

2. PA-catheter insertion for therapy of congestive heart failure decided upon by the attending cardiologist

The following will be considered as exclusion criteria for this study

1. Known or suspected septic shock or bacteremia

2. Active bleeding or HCT<24% at baseline

3. Arterial oxygen saturation <90% at baseline despite supplemental oxygen therapy.

4. Previous difficulty with venipuncture of upper extremity veins or the presence of a surgical arteriovenous fistula for hemodialysis

5. Insertion of the PA catheter through the femoral vein

6. Subjects unwilling or unable to provide written consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Other:
• Standard of care therapy for severe decompensated heart failure
Standard of care therapy for severe decompensated heart failure

Locations

Country	Name	City	State
United States	Massachusetts General Hospital, Coronary Care Unit	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Critical Diagnostics, Siemens Molecular Imaging

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the relationship between mixed venous, central venous, and peripheral venous oxygen saturation in patients with advanced (class III or IV) heart failure.		Day 0-5 of 'tailored' heart failure therapy	No
Secondary	To examine the relationship of selected cardiac biomarkers with cardiac filling pressures and cardiac output over time in patients with decompensated heart failure.		Days 0-5 of 'tailored' heart failure therapy	No