Cytokine REmoval in CRitically Ill PAtients Requiring Surgical Therapy for Infective Endocarditis (RECReATE) - an Investigator-initiated Prospective Randomized Controlled Clinical Trial Comparing Two Established Clinical Protocols
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Change in quantitative expression of monocytic Human Leukocyte Antigen (mHLA)-DR expression (Antibodies per cell on Cluster of Differentiation (CD)14+ monocytes/macrophages, assessed using a quantitative standardized assay)
研究概览
简要总结
Infectious endocarditis (IE) and other severe infections are well-known to induce significant changes in the immune response including immune functionality in a considerable number of affected patients. In fact, numerous patients with IE develop a persistent functional immunological phenotype that can best be characterized by a profound anti-inflammation and/or functional anergy. This was previously referred to as "injury-associated immunosuppression (IAI)" by Pfortmüller et al., published in Intensive Care Medicine Experimental 2017. IAI can be assessed by measurement of cellular (functional) markers. Persistence of IAI is associated with prolonged ICU length of stay, increased secondary infection rates, and death. Immunomodulation to reverse IAI was shown beneficial in immunostimulatory (randomized controlled) clinical trials. CytoSorb® treatment is currently used as standard of care in some institutions in surgically treated IE patients. The investigators aim to investigate two accepted treatment protocols and aim to explore whether adsorption with a cytokine adsorption filter can increase immune competence in treated individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects scheduled for routine cardiac surgery for infectious endocarditis (diagnosed according to the predefined "DUKE" criteria) with antibiotic therapy for ≤ 14 days.
- •Presence of informed consent
- •Age ≥18 yrs.
排除标准
- •Previous treatment (last 6 months) with immunologically-active biologicals or specific immunomodulatory drugs (e.g. Rituximab)
- •high-dose chronic (i.e. before onset of infectious endocarditis) steroid medication with prednisone equivalent of >30 mg/d
- •Patients on Extracorporeal membrane oxygenation (ECMO), or any other (pre-operative) cardiac assist device
- •Moribund patient (life expectancy <14 days)
结局指标
主要结局
Change in quantitative expression of monocytic Human Leukocyte Antigen (mHLA)-DR expression (Antibodies per cell on Cluster of Differentiation (CD)14+ monocytes/macrophages, assessed using a quantitative standardized assay)
时间窗: From baseline (pre-OR, t1) to day 1 post-OR (t3)
次要结局
- Change in inflammatory markers including cytokines (Interleukin (IL)-6, IL-10, C-reactive protein, White blood cell count, multiplex Enzyme linked immunosorbent assay, and inflammatory prohormones)(From baseline (pre-OR) to post-OR, and day 1 and 3 post-OR)
- ICU mortality rate(ICU stay (assessed at day 90))
- Change in mHLA-DR from baseline (pre-OR) to post-Or and 3 days post-Or.(Baseline (pre-OP) to post-OR and 3 days post-Or)
- Hospital mortality rate(hospital stay (assessed at day 90))
- Duration of renal replacement therapy(90 days)
- 90 day mortality rate(90 days beginning from ICU admission (assessed at day 90))
- Total amount of infused volume/transfusions on ICU(90 days)
- Area under the curve of quantitative mHLA-DR expression(Between baseline (pre-OR), post-OR, and day 1 and 3 post-OR (multiple assessments).)
- Duration of vasoactive drug therapy(90 days)
- Duration of invasive mechanical ventilation(90 days)
- 28 day mortality rate(28 days beginning from ICU admission (assessed at day 90))
- Change in organ dysfunction (Sepsis-related organ failure (SOFA) scores incl. subscores and Simplified acute physiology score (SAPS II scores) daily(7-day timeframe (starting from ICu admission, assessed at day 90))
- Length of ICU and hospital stay (days after surgical intervention).(Number of days on ICU and in hospital (assessed at day 90))
- Cumulative Therapeutic Intervention Scoring System (TISS) points (resource need) until ICU-discharge(Total number of TISS points on ICU (cumulative), assessed at day 90)
研究者
Jörg Schefold
Principal Investigator
Insel Gruppe AG, University Hospital Bern