Elimination of Cardiac and Inflammatory Biomarkers and Adipokines by Therapeutic Plasma Exchange
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Percentage decrease in serum levels of Troponin T by TPE
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •indication for TPE
- •age between 18 and 80 years
- •written informed consent
排除标准
- •need for fresh-frozen plasma as replacement fluid
- •participation in another study
结局指标
主要结局
Percentage decrease in serum levels of Troponin T by TPE
时间窗: Up to five days after enrollment
Elimination of cardiac biomarkers Troponin T by TPE measured by the decrease in serum levels after two consecutive TPE sessions.
Percentage decrease in serum levels of procalcitonin by TPE
时间窗: Up to five days after enrollment
Elimination of procalcitonin by TPE measured by the decrease in serum
Percentage decrease in serum levels of C-reactive protein by TPE
时间窗: Up to five days after enrollment
Elimination of C-reactive protein by TPE measured by the decrease in serum levels after two consecutive TPE sessions.
Percentage decrease in serum levels of NT-proBNP by TPE
时间窗: Up to five days after enrollment
Elimination of NT-proBNP by TPE measured
次要结局
- Total eliminated amount of NT-proBNP by TPE(Up to five days after enrollment)
- Total eliminated amount of procalcitonin by TPE(Up to five days after enrollment)
- Total eliminated amount of C-reactive protein by TPE(Up to five days after enrollment)
- Percentage decrease in serum levels of adipokines by TPE(Up to five days after enrollment)
- Total eliminated amount of Troponin T by TPE(Up to five days after enrollment)
- Total eliminated amount of adipokines by TPE(Up to five days after enrollment)