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Review
. 2024 Apr 1;52(4):521-530.
doi: 10.1097/CCM.0000000000006176. Epub 2024 Jan 19.

Position Paper on the Reporting of Norepinephrine Formulations in Critical Care from the Society of Critical Care Medicine and European Society of Intensive Care Medicine Joint Task Force

Patrick M Wieruszewski  1   2 , Marc Leone  3 , Benjamin Skov Kaas-Hansen  4 , Siddharth Dugar  5   6 , Matthieu Legrand  7 , Cathrine A McKenzie  8 , Brittany D Bissell Turpin  9   10 , Antonio Messina  11   12 , Prashant Nasa  13 , Christa A Schorr  14   15 , Jan J De Waele  16   17 , Ashish K Khanna  18   19
Affiliations
Review

Position Paper on the Reporting of Norepinephrine Formulations in Critical Care from the Society of Critical Care Medicine and European Society of Intensive Care Medicine Joint Task Force

Patrick M Wieruszewski et al. Crit Care Med. .

Abstract

Objectives: To provide guidance on the reporting of norepinephrine formulation labeling, reporting in publications, and use in clinical practice.

Design: Review and task force position statements with necessary guidance.

Setting: 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.

Subjects: 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.

Interventions: 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.

Measurements and main results: 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.

Conclusions: 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.

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Conflict of interest statement

Dr. Wieruszewski received funding from La Jolla Pharmaceutical Company. Dr. De Waele’s institution received funding from Menarini, MSD, Pfizer, Thermofisher, and Viatris. Dr. Leone received funding from LFB, Viatris, and Shionigi. Dr. Messina received funding from Vygon, Edwards, and Philips. Dr. McKenzie’s institution received funding from the National Institute of Health and Social Care Research, Wessex Applied Research Collaborative, and Pharmaceutical Press; she received funding from Sedana Medical and Southampton Research Leaders Programme. Ashish K. Khanna’s institution received funding from La Jolla Pharmaceuticals, Trevena Pharmaceuticals, and Edwards LifeSciences. He receives consulting fees from Medtronic, Edwards LifeSciences, Philips Research North America, GE Healthcare, Potrero Medical, Retia Medical, Pharmazz Inc. and Caretaker Medical. He receives grant funding from Hypertension and Vascular Research Center at the Wake Forest University School of Medicine (AG073581) to study mechanisms of renin dysregulation in shock. The remaining authors have disclosed that they do not have any potential conflicts of interest.

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