氯胺酮持续输注对重症监护病房患者的镇静和血流动力学影响（SHOCK-ICU）：探究关键结局、资源利用及医护人员决策：临床可行性研究方案

The Sedative and Haemodynamic effects Of Continuous Ketamine infusions on Intensive Care Unit patients (SHOCK-ICU): Investigating key outcomes, resource utilisation and staff decision-making: Clinical feasibility study protocol.

作者信息

Richards Nicholas D, Howell Simon J, Bellamy Mark C, Beck James, Tingerides Fiona, Mujica-Mota Ruben, Bekker Hilary L, Relton Samuel, Thorp Helen

机构信息

Adult Critical Care, Leeds Teaching Hospitals NHS Trust, Leeds, UK.

Leeds Institute of Medical Research, University of Leeds, Leeds, UK.

出版信息

J Intensive Care Soc. 2025 Mar 31;26(2):263-269. doi: 10.1177/17511437251327565. eCollection 2025 May.

DOI:10.1177/17511437251327565

PMID:40171294

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11955984/

Abstract

BACKGROUND

Between April 2022 and March 2023, 43.8% (88,259) patients admitted to Intensive Care Units (ICU) in the United Kingdom (UK) required breathing support through a ventilator, the majority require sedation. Unfortunately, mechanical ventilation is associated with high mortality and morbidity, and sedative agents currently used have significant side effects including hypotension and delirium. They are also implicated in long-term psychological sequelae such as major depression and posttraumatic stress disorder. Ketamine has been utilised in anaesthesia for over 50 years and has an excellent safety profile. The diverse properties of ketamine are the focus of much research currently, including its properties as a potent antidepressant. Ketamine has not been fully investigated in the context of ICU, and there are gaps in the evidence that warrant further investigation through a large randomised controlled trial. Preparatory work for such a study includes refining study designs, identifying key clinical and patient centred outcomes and exploring barriers to implementation, which is the focus of this work.

METHODS

SHOCK-ICU is a single centre, non-randomised, feasibility study assessing the feasibility of continuous ketamine infusions for the provision of sedation for 30 patients undergoing mechanical ventilation on the ICU.Data will be collected at baseline, daily until >48 h without mechanical ventilation, ICU discharge, and 90-days from enrolment. Data collection will include trial aspects such as expected recruitment, refusal, and follow-up rates, ability to collect data, and exploratory assessment of clinical efficacy markers.

PRIMARY OUTCOME

The primary outcome is study feasibility; this will be assessed using pre-defined progression criteria that will aid design of future ketamine sedation studies.

摘要

背景

2022年4月至2023年3月期间，英国重症监护病房（ICU）收治的患者中有43.8%（88259例）需要通过呼吸机进行呼吸支持，大多数患者需要镇静。不幸的是，机械通气与高死亡率和高发病率相关，目前使用的镇静剂有显著的副作用，包括低血压和谵妄。它们还与长期心理后遗症有关，如重度抑郁症和创伤后应激障碍。氯胺酮已在麻醉中使用了50多年，具有良好的安全性。氯胺酮的多种特性是目前许多研究的重点，包括其作为强效抗抑郁药的特性。氯胺酮在ICU环境中尚未得到充分研究，证据存在空白，需要通过大型随机对照试验进一步研究。此类研究的准备工作包括完善研究设计、确定关键的临床和以患者为中心的结局以及探索实施障碍，这是本研究的重点。

方法

SHOCK-ICU是一项单中心、非随机的可行性研究，评估持续输注氯胺酮为30例在ICU接受机械通气的患者提供镇静的可行性。将在基线时、每天直至无机械通气超过48小时、ICU出院时以及入组后90天收集数据。数据收集将包括试验方面的内容，如预期招募率、拒绝率和随访率；收集数据的能力；以及对临床疗效标志物的探索性评估。