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

NCT00595738 | Completed

• 1 other identifier: 2007P-000704
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Congestive Heart Failure

Keywords

Congestive heart failure; Cardiac biomarkers; Hemodynamics; Tailored therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (1)

Heart Failure Patients

Patients admitted with advanced heart failure for tailoring of heart failure therapy via placement of a pulmonary artery (PA) catheter. In our study, the patients will already have a PA catheter placed for clinical/treatment reasons when we approach them for the study.

Other: Standard of care therapy for severe decompensated heart failure

Interventions

Standard of care therapy for severe decompensated heart failure OTHER

Standard of care therapy for severe decompensated heart failure

Heart Failure Patients

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of 30 patients admitted to the Massachusetts General Hospital Coronary Care Unit (CCU) for PA catheter-directed therapy for advanced heart failure. Only patients for whom the attending cardiologist has already decided upon PA-catheter insertion will be recruited for the study. Potential subjects will be identified by the CCU attending cardiologist, and a study nurse will review each patient for the exclusion criteria as above. Final decisions on patient eligibility will be made by Dr. Wang.

You may qualify if:

• Age\>21
• PA-catheter insertion for therapy of congestive heart failure decided upon by the attending cardiologist

You may not qualify if:

• Known or suspected septic shock or bacteremia
• Active bleeding or HCT\<24% at baseline
• Arterial oxygen saturation \<90% at baseline despite supplemental oxygen therapy.
• Previous difficulty with venipuncture of upper extremity veins or the presence of a surgical arteriovenous fistula for hemodialysis
• Insertion of the PA catheter through the femoral vein
• Subjects unwilling or unable to provide written consent

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Siemens Molecular Imaging: collaborator
• Critical Diagnostics: collaborator

Study Sites (1)

Massachusetts General Hospital, Coronary Care Unit

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Zilinski JL, Shah RV, Gaggin HK, Gantzer ML, Wang TJ, Januzzi JL. Measurement of multiple biomarkers in advanced stage heart failure patients treated with pulmonary artery catheter guided therapy. Crit Care. 2012 Jul 25;16(4):R135. doi: 10.1186/cc11440.

  PMID: 22830581 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

We will be banking serum collected from peripheral blood draws, and blood draws from a pulmonary artery catheter and arterial line.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Thomas J Wang, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• James Januzzi, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 7, 2008
• First Posted: January 16, 2008
• Study Start: December 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: January 1, 2011
• Last Updated: July 20, 2011

Record last verified: 2011-07

Locations

US (1)