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Completed

NCT Number: NCT00595738

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

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.

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Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital, Coronary Care Unit

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

The following inclusion criteria will be utilized:

  • Age>21
  • 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

  • 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

Treatment and study plan

Standard of care therapy for severe decompensated heart failure

Other

Standard of care therapy for severe decompensated heart failure

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.

    Time frame: 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.

    Time frame: Days 0-5 of 'tailored' heart failure therapy

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Critical Diagnostics
  • Siemens Molecular Imaging

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Jan 16, 2008
Registry last updated
Jul 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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