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

Author:

Wieruszewski Patrick M.12,Leone Marc3,Kaas-Hansen Benjamin Skov4,Dugar Siddharth56,Legrand Matthieu7,McKenzie Cathrine A.8,Bissell Turpin Brittany D.910,Messina Antonio1112,Nasa Prashant13,Schorr Christa A.1415,De Waele Jan J.1617,Khanna Ashish K.1819

Affiliation:

1. Department of Pharmacy, Mayo Clinic, Rochester, MN.

2. Department of Anesthesiology, Mayo Clinic, Rochester, MN.

3. Department of Anesthesiology and Intensive Care Medicine, Nord Hospital, Assistance Publique Hôpitaux Universitaires de Marseille, Aix Marseille University, Marseille, France.

4. Department of Intensive Care, Copenhagen University Hospital—Rigshospitalet, Copenhagen, Denmark.

5. Department of Critical Care, Respiratory Institute, Cleveland Clinic, Cleveland, OH.

6. Cleveland Clinic Lerner College of Medicine, Cleveland, OH.

7. Division of Critical Care Medicine, Department of Anesthesiology and Perioperative Care, University of California San Francisco, San Francisco, CA.

8. Department of Clinical and Experimental Medicine, School of Medicine, University of Southampton, National Institute of Health and Care Research (NIHR), Southampton Biomedical Research Centre, Perioperative and Critical Care Theme, and NIHR Wessex Applied Research Collaborative, Southampton, United Kingdom.

9. Ephraim McDowell Regional Medical Center, Danville, KY.

10. Department of Pharmacy, University of Kentucky, Lexington, KY.

11. Department of Anesthesia and Intensive Care, IRCCS Humanitas Research Hospital, Rozzano (MI), Italy.

12. Department of Biomedical Sciences, Humanitas University, Pieve Emanuele (MI), Italy.

13. Department of Critical Care Medicine, NMC Specialty Hospital, Dhabi, United Arab Emirates.

14. Cooper Department of Medicine, Cooper Research Institute, Cooper University Hospital, Camden, NJ.

15. Cooper Medical School at Rowan University, Camden, NJ.

16. Department of Intensive Care Medicine, Ghent University Hospital, Ghent, Belgium.

17. Department of Internal Medicine and Pediatrics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.

18. Department of Anesthesiology, Section on Critical Care Medicine, Wake Forest University School of Medicine, Atrium Health Wake Forest Baptist Medical Center, Winston-Salem, NC.

19. Outcomes Research Consortium, Cleveland, OH.

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.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Critical Care and Intensive Care Medicine

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