A noticeable interest in ketamine infusion for sedation management has developed among critical care physicians for critically ill patients. The 2018 Pain, Agitation/sedation, Delirium, Immobility, and Sleep disruption guideline suggested low-dose ketamine infusion as an adjunct to opioid therapy to reduce opioid requirements in post-surgical patients in the intensive care unit (ICU). This was, however, rated as conditional due to the very low quality of evidence. Ketamine has favorable characteristics, making it an especially viable alternative for patients with respiratory and hemodynamic instability. The Analgo-sedative adjuncT keTAmine Infusion iN Mechanically vENTilated ICU patients (ATTAINMENT) trial aims to assess the effect and safety of adjunct low-dose continuous infusion of ketamine as an analgo-sedative compared to standard of care in critically ill patients on mechanical ventilation (MV) for ≥ 24 h. This trial is a prospective, randomized, active controlled, open-label, pilot, feasibility study of adult ICU patients (> 14 years old) on MV. The study will take place in the adult ICUs in the King Faisal Specialist Hospital and Research Center (KFSH&RC), Riyadh, Saudi Arabia, and will enroll 80 patients. Patients will be randomized post-intubation into two groups: the intervention group will receive an adjunct low-dose continuous infusion of ketamine plus standard of care. Ketamine will be administered over a period of 48 h at a fixed infusion rate of 2 μg/kg/min (0.12 mg/kg/h) in the first 24 h followed by 1 μg/kg/min (0.06 mg/kg/h) in the second 24 h. The control group will receive standard of care in the ICU (propofol and/or fentanyl and/or midazolam) according to the KFSH&RC sedation and analgesia protocol as clinically appropriate. The primary outcome is MV duration until ICU discharge, death, extubation, or 28 days post-randomization, whichever comes first. The first patient was enrolled on 1 September 2019. As of 10 October 2019, a total of 16 patients had been enrolled. We expect to complete the recruitment by 31 December 2020. The findings of this pilot trial will likely justify further investigation for the role of adjunct low-dose ketamine infusion as an analgo-sedative agent in a larger, multicenter, randomized controlled trial. ClinicalTrials.gov: NCT04075006. Registered on 30 August 2019. Current controlled trials: ISRCTN14730035. Registered on 3 February 2020.

中文翻译：

---

沙特第三医院机械通气危重患者辅助低剂量氯胺酮输注与标准治疗（ATTAINMENT试验）：一项随机，前瞻性，先导，可行性试验的研究方案

在危重病人的重症监护医师中，氯胺酮输注用于镇静管理的兴趣显着提高。2018年的疼痛，躁动/镇静，Deli妄，运动不便和睡眠中断指南建议，低剂量氯胺酮输注可作为阿片类药物的辅助疗法，以减少重症监护病房（ICU）术后患者的阿片类药物需求。但是，由于证据质量很低，因此被认为是有条件的。氯胺酮具有良好的特性，使其成为呼吸系统和血液动力学不稳定患者的特别可行的选择。在机械通气的ICU患者中使用镇静性辅助酮胺输注（ATTAINMENT）试验旨在评估与机械通气危重患者相比，低剂量连续小剂量氯胺酮作为镇静剂的辅助镇静剂的治疗效果和安全性（ MV）≥24小时。该试验是对成年ICU患者（> 14岁）进行MV的前瞻性，随机，主动控制，开放标签，试验性，可行性研究。这项研究将在沙特阿拉伯利雅德的费萨尔国王专科医院和研究中心（KFSH＆RC）的成人ICU中进行，招募80名患者。患者将在插管后随机分为两组：干预组将接受低剂量氯胺酮的持续低剂量连续输注以及标准护理。在开始的24小时内，氯胺酮将在48小时内以2μg/ kg / min（0.12 mg / kg / h）的固定输注速率给药，随后是1μg/ kg / min（0.06 mg / kg / h） ）在第二个24小时内。对照组将根据临床上适当的KFSH＆RC镇静和镇痛方案在ICU（丙泊酚和/或芬太尼和/或咪达唑仑）中接受护理标准。主要结局是MV持续时间，直至ICU出院，死亡，拔管或随机分配后28天，以先到者为准。第一名患者已于2019年9月1日入选。截至2019年10月10日，共有16名患者入选。我们预计将在2020年12月31日之前完成招募工作。这项试验性试验的结果可能会为进一步调查低剂量氯胺酮辅助输注在较大的多中心镇痛镇痛剂中的作用提供依据。随机对照试验。ClinicalTrials.gov：NCT04075006。2019年8月30日注册。目前的对照试验：ISRCTN14730035。于2020年2月3日注册。