背景:横纹肌溶解症是一种严重的疾病,需要肾脏替代疗法(RRT),可导致急性肾损伤。细胞因子吸附剂Cytosorb®(CS)可用于横纹肌溶解症患者的体外肌红蛋白消除。然而,吸附容量和饱和动力学的数据仍然缺失。
方法:前瞻性Cyto-SOLVE研究(NCT04913298)包括20名重症监护病房严重横纹肌溶解症患者(血浆肌红蛋白>5000ng/ml),由于急性肾损伤和使用CS用于肌红蛋白消除的RRT。在确定的时间点(十分钟,一,三,六,和开始后十二小时)。我们计算了相对变化(RC,%)带有:[公式:见文本]。肌红蛋白血浆清除率(ml/min)计算如下:[公式:参见正文]结果:安装CS后6小时,肌红蛋白血浆浓度显着降低(中位数(IQR)56,894ng/ml(11,544;102,737ng/ml)与40,125ng/ml(7879;75,638ng/ml)(p<0.001)。12小时后没有观察到显著的变化。在所有时间点(p<0.05)(十分钟,一,三,六,和开始后十二小时)。上述时间点肌红蛋白的中位数(IQR)RC为-79.2%(-85.1;-47.1%),-34.7%(-42.7;-18.4%),-16.1%(-22.1;-9.4%),-8.3%(-7.5;-1.3%),和-3.9%(-3.9;-1.3%),分别。开始CS治疗后10分钟,肌红蛋白血浆清除率中位数为64.0ml/min(58.6;73.5ml/min),迅速降低至29.1ml/min(26.5;36.1ml/min),16.1ml/min(11.9;22.5ml/min),7.9ml/min(5.5;12.5ml/min),和3.7毫升/分钟(2.4;6.4毫升/分钟)后,三,六,十二个小时,分别。
结论:Cytosorb®吸附剂有效地消除了肌红蛋白。然而,吸附能力在约3小时后迅速下降,导致有效性降低。严重横纹肌溶解症患者吸附剂的早期改变可能会增加疗效。临床获益应在进一步的临床试验中进行研究。
背景:ClinicalTrials.govNCT04913298。2021年5月7日注册,https//clinicaltrials.gov/study/NCT04913298。
BACKGROUND: Rhabdomyolysis is a serious condition that can lead to acute kidney injury with the need of renal replacement therapy (RRT). The cytokine adsorber Cytosorb® (CS) can be used for extracorporeal myoglobin elimination in patients with rhabdomyolysis. However, data on adsorption capacity and saturation kinetics are still missing.
METHODS: The prospective Cyto-SOLVE
study (NCT04913298) included 20 intensive care unit patients with severe rhabdomyolysis (plasma myoglobin > 5000 ng/ml), RRT due to acute kidney injury and the use of CS for myoglobin elimination. Myoglobin and creatine kinase (CK) were measured in the patient´s blood and pre- and post-CS at defined time points (ten minutes, one, three, six, and twelve hours after initiation). We calculated Relative Change (RC, %) with: [Formula: see text]. Myoglobin plasma clearances (ml/min) were calculated with: [Formula: see text] RESULTS: There was a significant decrease of the myoglobin plasma concentration six hours after installation of CS (median (IQR) 56,894 ng/ml (11,544; 102,737 ng/ml) vs. 40,125 ng/ml (7879; 75,638 ng/ml) (p < 0.001). No significant change was observed after twelve hours. Significant extracorporeal adsorption of myoglobin can be seen at all time points (p < 0.05) (ten minutes, one, three, six, and twelve hours after initiation). The median (IQR) RC of myoglobin at the above-mentioned time points was - 79.2% (-85.1; -47.1%), -34.7% (-42.7;-18.4%), -16.1% (-22.1; -9.4%), -8.3% (-7.5; -1.3%), and - 3.9% (-3.9; -1.3%), respectively. The median myoglobin plasma clearance ten minutes after starting CS treatment was 64.0 ml/min (58.6; 73.5 ml/min), decreasing rapidly to 29.1 ml/min (26.5; 36.1 ml/min), 16.1 ml/min (11.9; 22.5 ml/min), 7.9 ml/min (5.5; 12.5 ml/min), and 3.7 ml/min (2.4; 6.4 ml/min) after one, three, six, and twelve hours, respectively.
CONCLUSIONS: The Cytosorb® adsorber effectively eliminates myoglobin. However, the adsorption capacity decreased rapidly after about three hours, resulting in reduced effectiveness. Early change of the adsorber in patients with severe rhabdomyolysis might increase the efficacy. The clinical benefit should be investigated in further clinical trials.
BACKGROUND: ClinicalTrials.gov NCT04913298. Registered 07 May 2021, https//clinicaltrials.gov/
study/NCT04913298.