Elimination of Cardiac and Inflammatory Biomarkers and Adipokines by Therapeutic Plasma Exchange

Study Overview
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Brief Summary
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Therapeutic plasma exchange (TPE) is an established treatment modality for the acute removal of pathophysiological relevant mediators in various diseases. Adipokines have recently been found to play an important role in a variety of immunologic diseases. However, in many of these disease states cardiac and inflammatory involvement is common and biomarkers are routinely used for diagnosis or assessment of therapeutic success. The effect of TPE on biomarkers used in the clinical routine has not been investigated. The aim of this study is to determine adipokine and cardiac biomarker removal during TPE therapy.

Detailed Description
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We performed a observational prospective single-centered study. Every patient received two consecutive therapeutic plasma exchange (TPE) sessions during the study. Plasma exchange therapy was performed using either the Spectra Optia® or the Octo Nova® apheresis system. Anticoagulation was applied either by heparin or citrate. The prescribed dose of exchange volume of every TPE treatment was 1.1-times the individual calculated total plasma volume, using the Nadler-Allen equation. A substitute fluid with 5% albumin concentration was used in every treatment. Blood samples for measurement of different adipokines (resistin, leptin, soluble ICAM-1, soluble CD40 ligand, monocyte chemoattractant protein-1 (MCP-1), soluble tumor necrosis factor receptor (sTNF-R) as well as cardiac and inflammatory biomarkers and routine chemistry were drawn before (pre-TPE) and at the end (post-TPE) of the first and second TPE session.

Official Title
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Elimination of Cardiac and Inflammatory Biomarkers and Adipokines by Therapeutic Plasma Exchange

Conditions
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Antibody-mediated Rejection, Autoimmune Reaction Mediated by Immune Complex

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: indication for TPE age between 18 and 80 years written informed consent Exclusion Criteria: need for fresh-frozen plasma as replacement fluid participation in another study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage decrease in serum levels of C-reactive protein by TPE | Elimination of C-reactive protein by TPE measured by the decrease in serum levels after two consecutive TPE sessions. | Up to five days after enrollment | 
| Percentage decrease in serum levels of Troponin T by TPE | Elimination of cardiac biomarkers Troponin T by TPE measured by the decrease in serum levels after two consecutive TPE sessions. | Up to five days after enrollment | 
| Percentage decrease in serum levels of procalcitonin by TPE | Elimination of procalcitonin by TPE measured by the decrease in serum | Up to five days after enrollment | 
| Percentage decrease in serum levels of NT-proBNP by TPE | Elimination of NT-proBNP by TPE measured | Up to five days after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage decrease in serum levels of adipokines by TPE | Elimination of adipokines by TPE measured by the decrease in serum levels after two consecutive TPE sessions. | Up to five days after enrollment | 
| Total eliminated amount of Troponin T by TPE | Elimination of Troponin T by TPE measured by the total eliminated amount in the exchanged plasma. | Up to five days after enrollment | 
| Total eliminated amount of NT-proBNP by TPE | Elimination of NT-proBNP by TPE measured by the total eliminated amount in the exchanged plasma. | Up to five days after enrollment | 
| Total eliminated amount of procalcitonin by TPE | Elimination of procalcitonin by TPE measured by the total eliminated amount in the exchanged plasma. | Up to five days after enrollment | 
| Total eliminated amount of C-reactive protein by TPE | Elimination of C-reactive protein by TPE measured by the total eliminated amount in the exchanged plasma. | Up to five days after enrollment | 
| Total eliminated amount of adipokines by TPE | Elimination of adipokines by TPE measured by the total eliminated amount in the exchanged plasma. | Up to five days after enrollment |