Erdoes Gabor, Uehlinger Dominik E, Kobel Beatrice, Stucki Monika P, Wiest Roland, Stueber Frank, Fankhauser Niklaus, Jakob Stephan M, Schefold Joerg C
Department of Anesthesiology and Pain Therapy, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, 3010, Bern, Switzerland.
Department of Nephrology and Hypertension, Bern University Hospital, University of Bern, 3010, Bern, Switzerland.
Trials. 2018 Mar 21;19(1):189. doi: 10.1186/s13063-018-2561-3.
Microembolism is a frequent pathological event during extracorporeal renal replacement therapy (RRT). Some previous data indicate that microemboli are generated in patients who are undergoing RRT and that these may contribute to increased cerebrovascular and neurocognitive morbidity in patients with end-stage renal disease. The current trial aims to quantify the microembolic load and respective qualitative composition that effectively reaches the intracerebral circulation in critically ill patients treated with different RRT modalities for acute kidney injury (AKI).
METHODS/DESIGN: The COMET-AKI trial is a prospective, randomized controlled clinical trial with a 2-day clinical assessment period and follow-up visits at 6 and 12 months. Consecutive critically ill patients with AKI on continuous renal replacement therapy (CRRT) scheduled for a switch to intermittent renal replacement therapy (IRRT) will be randomized to either switch to IRRT within the next 24 h or continued CRRT for an additional 24 h. Cerebral microembolic load will be determined at baseline, i.e., before switch (on CRRT for both groups) and on IRRT versus CRRT, whichever group they were randomized to. The primary endpoint is defined as the difference in mean total cerebral microemboli count during the measurement period on CRRT versus IRRT following randomization. Microemboli will be assessed within the RRT circuit by a 1.5-MHz ultrasound detector attached to the venous RRT tubing and cerebral microemboli will be measured in the middle cerebral artery using a 1.6-MHz robotic transcranial Doppler system with automatic classification of Doppler signals as solid or gaseous. In addition to Doppler measurements, patients will be examined by magnetic resonance imaging and neurocognitive tests to gain better understanding into the potential morphological and clinical consequences of embolization.
The results of COMET-AKI may help to gain a better insight into RRT modality-associated differences regarding microbubble generation and the cerebral microembolic burden endured by RRT recipients. Furthermore, identification of covariates of microbubble formation and distribution may help to encourage the evolution of next-generation RRT circuits including machinery and/or filters.
ClinicalTrials.gov, ID: NCT02621749 . Registered on 3 December 2015.
微栓塞是体外肾脏替代治疗（RRT）期间常见的病理事件。先前的一些数据表明，接受RRT的患者会产生微栓子，这些微栓子可能会导致终末期肾病患者的脑血管疾病和神经认知疾病发病率增加。当前试验旨在量化接受不同RRT模式治疗急性肾损伤（AKI）的危重症患者有效进入脑循环的微栓子负荷及其定性组成。
方法/设计：COMET-AKI试验是一项前瞻性随机对照临床试验，有2天的临床评估期，并在6个月和12个月时进行随访。计划从持续肾脏替代治疗（CRRT）转为间歇性肾脏替代治疗（IRRT）的连续性AKI危重症患者将被随机分为两组，一组在接下来的24小时内转为IRRT，另一组继续进行CRRT额外24小时。脑微栓子负荷将在基线时测定，即在转换前（两组均为CRRT状态）以及在随机分组后接受IRRT或CRRT治疗时测定。主要终点定义为随机分组后，CRRT与IRRT测量期内平均总脑微栓子计数的差异。微栓子将通过连接到静脉RRT管路的1.5MHz超声探测器在RRT回路内进行评估，脑微栓子将使用1.6MHz机器人经颅多普勒系统在大脑中动脉进行测量，并将多普勒信号自动分类为固体或气体。除了多普勒测量外，患者还将接受磁共振成像和神经认知测试，以更好地了解栓塞的潜在形态学和临床后果。
COMET-AKI试验的结果可能有助于更好地了解RRT模式在微泡生成以及RRT接受者所承受的脑微栓子负担方面的差异。此外，识别微泡形成和分布的协变量可能有助于推动包括设备和/或过滤器在内的下一代RRT回路的发展。
ClinicalTrials.gov，ID：NCT02621749。于2015年12月3日注册。
