Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum Knappschaftskrankenhaus Bochum, Bochum, Germany
Faculty of Medicine - LMU, Walter-Brendel Center of Experimental Medicine, München, Germany.
BMJ Open. 2020 Jul 8;10(7):e038532. doi: 10.1136/bmjopen-2020-038532.
Sepsis is defined as detrimental immune response to an infection. This overwhelming reaction often abolishes a normal reconstitution of the immune cell homeostasis that in turn increases the risk for further complications. Recent studies revealed a favourable impact of ketone bodies on resolution of inflammation. Thus, a ketogenic diet may provide an easy-to-apply and cost-effective treatment option potentially alleviating sepsis-evoked harm. This study is designed to assess the feasibility, efficiency and safety of a ketogenic diet in septic patients.
This monocentric study is a randomised, controlled and open-label trial, which is conducted on an intensive care unit of a German university hospital. As intervention enteral nutrition with reduced amount of carbohydrates (ketogenic) or standard enteral nutrition (control) is applied. The primary endpoint is the detection of ketone bodies in patients' blood and urine samples. As secondary endpoints, the impact on important safety-relevant issues (eg, glucose metabolism, lactate serum concentration, incidence of metabolic acidosis, thyroid function and 30-day mortality) and the effect on the immune system are analysed.
The study has received the following approvals: Ethics Committee of the Medical Faculty of Ruhr-University Bochum (No. 18-6557-BR). Results will be made available to critical care survivors, their caregivers, the funders, the critical care societies and other researchers by publication in a peer-reviewed journal.
German Clinical Trial Register (DRKS00017710); Universal Trial Number (U1111-1237-2493).
败血症被定义为对感染的有害免疫反应。这种压倒性的反应通常会破坏免疫细胞内稳态的正常重建，从而增加进一步并发症的风险。最近的研究表明酮体对炎症消退有有利影响。因此，生酮饮食可能提供一种易于应用且具有成本效益的治疗选择，潜在缓解败血症引起的伤害。本研究旨在评估生酮饮食在败血症患者中的可行性、效率和安全性。
这是一项单中心研究，是一项随机、对照、开放标签试验，在德国一所大学医院的重症监护病房进行。作为干预的是减少碳水化合物量的肠内营养（生酮）或标准肠内营养（对照）。主要终点是检测患者血液和尿液样本中的酮体。次要终点包括对重要安全相关问题（如葡萄糖代谢、血清乳酸浓度、代谢性酸中毒发生率、甲状腺功能和 30 天死亡率）的影响以及对免疫系统的影响进行分析。
该研究已获得以下批准：鲁尔大学波鸿医学伦理委员会（编号 18-6557-BR）。结果将通过在同行评议的期刊上发表，提供给重症监护幸存者、他们的护理人员、资助者、重症监护协会和其他研究人员。
德国临床试验注册处（DRKS00017710）；通用试验编号（U1111-1237-2493）。
