Department of Pharmacy, Mayo Clinic, Rochester, MN.
Department of Anesthesiology, Mayo Clinic, Rochester, MN.
Crit Care Med. 2024 Apr 1;52(4):521-530. doi: 10.1097/CCM.0000000000006176. Epub 2024 Jan 19.
To provide guidance on the reporting of norepinephrine formulation labeling, reporting in publications, and use in clinical practice.
Review and task force position statements with necessary guidance.
A series of group conference calls were conducted from August 2023 to October 2023, along with a review of the available evidence and scope of the problem.
A task force of multinational and multidisciplinary critical care experts assembled by the Society of Critical Care Medicine and the European Society of Intensive Care Medicine.
The implications of a variation in norepinephrine labeled as conjugated salt (i.e., bitartrate or tartrate) or base drug in terms of effective concentration of norepinephrine were examined, and guidance was provided.
There were significant implications for clinical care, dose calculations for enrollment in clinical trials, and results of datasets reporting maximal norepinephrine equivalents. These differences were especially important in the setting of collaborative efforts across countries with reported differences.
A joint task force position statement was created outlining the scope of norepinephrine-dose formulation variations, and implications for research, patient safety, and clinical care. The task force advocated for a uniform norepinephrine-base formulation for global use, and offered advice aimed at appropriate stakeholders.
提供关于去甲肾上腺素制剂标签报告、出版物报告以及临床实践使用的指导。
审查和工作组立场声明,并提供必要的指导。
2023 年 8 月至 10 月期间,通过一系列小组电话会议进行了审查,并对现有证据和问题范围进行了审查。
由重症监护医学学会和欧洲重症监护医学学会召集的多国家和多学科重症监护专家工作组。
研究了去甲肾上腺素标记为结合盐(即酒石酸盐或酒石酸)或基础药物时有效去甲肾上腺素浓度的变化所带来的影响,并提供了指导。
这对临床护理、临床试验入组时的剂量计算以及报告最大去甲肾上腺素等效物的数据集结果都有重大影响。这些差异在报告存在差异的国家之间的合作努力中尤为重要。
创建了一份联合工作组立场声明,概述了去甲肾上腺素剂量制剂变化的范围,以及对研究、患者安全和临床护理的影响。该工作组主张在全球范围内使用统一的去甲肾上腺素基础制剂,并为相关利益攸关方提供了建议。