Clinical trial NCT02533596: Elimination of Cardiac and Inflammatory Biomarkers and Adipokines by Therapeutic Plasma Exchange
Official title: Elimination of Cardiac and Inflammatory Biomarkers and Adipokines by Therapeutic Plasma Exchange
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antibody-mediated Rejection
Autoimmune Reaction Mediated by Immune Complex
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2015-08-27
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Tertiary hospital patients after kidney transplantation with humoral rejection and patients with other antibody mediated diseases.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage decrease in serum levels of C-reactive protein by TPE
timeFrame: Up to five days after enrollment
measure: Percentage decrease in serum levels of Troponin T by TPE
timeFrame: Up to five days after enrollment
measure: Percentage decrease in serum levels of procalcitonin by TPE
timeFrame: Up to five days after enrollment
measure: Percentage decrease in serum levels of NT-proBNP by TPE
timeFrame: Up to five days after enrollment
Secondary outcomes:
measure: Percentage decrease in serum levels of adipokines by TPE
timeFrame: Up to five days after enrollment
measure: Total eliminated amount of Troponin T by TPE
timeFrame: Up to five days after enrollment
measure: Total eliminated amount of NT-proBNP by TPE
timeFrame: Up to five days after enrollment
measure: Total eliminated amount of procalcitonin by TPE
timeFrame: Up to five days after enrollment
measure: Total eliminated amount of C-reactive protein by TPE
timeFrame: Up to five days after enrollment
measure: Total eliminated amount of adipokines by TPE
timeFrame: Up to five days after enrollment
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
Study officials:
affiliation: Hannover Medical School
name: Jan T Kielstein, Prof.
role: PRINCIPAL_INVESTIGATOR
References: