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

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ClinicalTrials.gov Identifier: NCT00595738
Recruitment Status : Completed
First Posted : January 16, 2008
Last Update Posted : July 20, 2011
Sponsor:
Collaborators:
Siemens Molecular Imaging
Critical Diagnostics
Information provided by:
Massachusetts General Hospital

Tracking Information
First Submitted Date January 7, 2008
First Posted Date January 16, 2008
Last Update Posted Date July 20, 2011
Study Start Date December 2007
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 7, 2008)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 7, 2008)
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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Peripheral Venous Oxygen Saturation and Biomarkers to Estimate Cardiac Output and Filling Pressures in Heart Failure
Official Title Use of Peripheral Venous Oxygen Saturation and Biomarkers to Estimate Cardiac Output and Filling Pressures in Patients With Advanced Heart Failure
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
We will be banking serum collected from peripheral blood draws, and blood draws from a pulmonary artery catheter and arterial line.
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.

Condition Congestive Heart Failure
Intervention Other: Standard of care therapy for severe decompensated heart failure
Standard of care therapy for severe decompensated heart failure
Study Groups/Cohorts 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.
Intervention: Other: Standard of care therapy for severe decompensated heart failure
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: January 7, 2008)
30
Original Estimated Enrollment Same as current
Actual Study Completion Date January 2011
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00595738
Other Study ID Numbers 2007P-000704
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Thomas J. Wang, MD, Massachusetts General Hospital
Study Sponsor Massachusetts General Hospital
Collaborators
  • Siemens Molecular Imaging
  • Critical Diagnostics
Investigators
Principal Investigator: Thomas J Wang, MD Massachusetts General Hospital
Principal Investigator: James Januzzi, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date July 2011