open access publication

Article, 2024

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

Critical Care Medicine, ISSN 1530-0293, 0090-3493, Volume 52, 4, Pages 521-530, 10.1097/ccm.0000000000006176

Contributors

Wieruszewski, Patrick M 0000-0002-5871-5186 [1] Leone, Marc 0000-0002-3097-758X [2] Kaas-Hansen, Benjamin Skov 0000-0003-1023-0371 [3] Dugar, Siddharth Pawan 0000-0002-3243-1417 [4] [5] Legrand, Matthieu [6] Mckenzie, Cathrine Anne 0000-0002-5190-9711 [7] Bissell Turpin, Brittany D [8] [9] Messina, Antonio 0000-0002-9744-1659 [10] [11] Nasa, Prashant 0000-0003-1948-4060 [12] Schorr, Christa A 0000-0001-7777-4280 [13] [14] De Waele, Jan J 0000-0003-1017-9748 [15] [16] Khanna, Ashish K 0000-0002-9083-891X (Corresponding author) [17] [18]

Affiliations

  1. [1] Mayo Clinic
  2. [NORA names: United States; America, North; OECD];
  3. [2] Aix-Marseille University
  4. [NORA names: France; Europe, EU; OECD];
  5. [3] Rigshospitalet
  6. [NORA names: Capital Region of Denmark; Hospital; Denmark; Europe, EU; Nordic; OECD];
  7. [4] Cleveland Clinic
  8. [NORA names: United States; America, North; OECD];
  9. [5] Cleveland Clinic Lerner College of Medicine
  10. [NORA names: United States; America, North; OECD];

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.

Keywords

European, European Society, European Society of Intensive Care Medicine, Joint Task Force, Society of Critical Care Medicine, Task Force, advice, base, base drugs, calculations, calls, care, care experts, care medicine, clinical care, clinical practice, clinical trials, collaborative efforts, concentrations of norepinephrine, conference calls, conjugated salts, countries, critical care, critical care experts, critical care medicine, criticism, dataset, differences, dose, dose calculation, drug, effective concentration, effective concentration of norepinephrine, efforts, enrollment, equivalence, evidence, experts, force, formulation, formulation variations, global use, guidance, intensive care medicine, labeling, medicine, norepinephrine, norepinephrine equivalents, paper, patient safety, patients, position, position paper, position statement, practice, problem, publications, reports, research, results, review, safety, salt, scope, series, society, stakeholders, statements, task, trials, use, variation

Funders

  • Menarini Group (Italy)
  • MSD (United States)
  • Philips (United States)
  • Pfizer (United States)
  • National Institute on Aging
  • Edwards Lifesciences (United States)

Data Provider: Digital Science