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

NCT ID: NCT00595738

Last Updated: 2011-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-12-31

Study Completion Date

2011-01-31

Brief Summary

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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

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Conditions

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Congestive Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Standard of care therapy for severe decompensated heart failure

Intervention Type OTHER

Standard of care therapy for severe decompensated heart failure

Interventions

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Standard of care therapy for severe decompensated heart failure

Standard of care therapy for severe decompensated heart failure

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Siemens Molecular Imaging

INDUSTRY

Sponsor Role collaborator

Critical Diagnostics

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Massachusetts General Hospital

Principal Investigators

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Thomas J Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

James Januzzi, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital, Coronary Care Unit

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 22830581 (View on PubMed)

Other Identifiers

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2007P-000704

Identifier Type: -

Identifier Source: org_study_id

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