Display options
Cite
Vandervelden S, Wauters L, Breuls J, et al. Early administration of Vitamin C in patients with sepsis or septic shock in emergency departments: A multicenter, double blinded, randomized controlled trial: The C-EASIE trial protocol. PLoS One. 2021;16(11):e0259699doi: 10.1371/journal.pone.0259699.
Vandervelden, S., Wauters, L., Breuls, J., Fieuws, S., Vanhove, P., Hubloue, I., Bartiaux, M., Creteur, J., Stifkens, F., Monsieurs, K., & Desruelles, D. (2021). Early administration of Vitamin C in patients with sepsis or septic shock in emergency departments: A multicenter, double blinded, randomized controlled trial: The C-EASIE trial protocol. PloS one, 16(11), e0259699. https://doi.org/10.1371/journal.pone.0259699
Vandervelden, Stefanie, et al. "Early administration of Vitamin C in patients with sepsis or septic shock in emergency departments: A multicenter, double blinded, randomized controlled trial: The C-EASIE trial protocol." PloS one vol. 16,11 (2021): e0259699. doi: https://doi.org/10.1371/journal.pone.0259699
Vandervelden S, Wauters L, Breuls J, Fieuws S, Vanhove P, Hubloue I, Bartiaux M, Creteur J, Stifkens F, Monsieurs K, Desruelles D. Early administration of Vitamin C in patients with sepsis or septic shock in emergency departments: A multicenter, double blinded, randomized controlled trial: The C-EASIE trial protocol. PLoS One. 2021 Nov 05;16(11):e0259699. doi: 10.1371/journal.pone.0259699. eCollection 2021. PMID: 34739527; PMCID: PMC8570477.
Copy Download .nbib Format: NLM
Share it on

PLoS One. 2021 Nov 05;16(11):e0259699. doi: 10.1371/journal.pone.0259699. eCollection 2021.

Early administration of Vitamin C in patients with sepsis or septic shock in emergency departments: A multicenter, double blinded, randomized controlled trial: The C-EASIE trial protocol.

PloS one

Stefanie Vandervelden, Lina Wauters, Jan Breuls, Steffen Fieuws, Philippe Vanhove, Ives Hubloue, Magali Bartiaux, Jacques Creteur, François Stifkens, Koen Monsieurs, Didier Desruelles

Affiliations

  1. Department of Emergency Medicine, University Hospitals Leuven, Leuven, Belgium.
  2. Department of Emergency Medicine, Algemeen Ziekenhuis Turnhout, Rubensstraat, Turnhout, Belgium.
  3. Leuven Biostatistics and Statistical Bioinformatics Center (L-BioStat), Kapucijnenvoer, Leuven, Belgium.
  4. Department of Intensive Care, GZA Ziekenhuizen, Antwerpen, Belgium.
  5. Department of Emergency Medicine, University Hospitals Brussel, Jette, Belgium.
  6. Department of Emergency Medicine, University Medical Center Saint Pierre, Bruxelles, Belgium.
  7. Department of Intensive Care, Erasme Hospital Brussels, Bruxelles, Belgium.
  8. Department of Emergency Medicine, Center Hospitalier Universitaire de Liège, Liège, Belgium.
  9. Department of Emergency Medicine, University Hospitals Antwerp, Edegem, Belgium.

PMID: 34739527 PMCID: PMC8570477 DOI: 10.1371/journal.pone.0259699

Abstract

BACKGROUND: Sepsis is a potentially life-threatening condition characterized by a deregulated body's response to infection causing injury to its own tissues and organs. Sepsis is the primary cause of death from infection. If not recognized and treated timely, it can evolve within minutes/hours to septic shock. Sepsis is associated with an acute deficiency of Vitamin C. Despite the proof-of-concept of the benefit of administering Vitamin C in patients with sepsis or septic shock, Vitamin C administration is not yet current practice.

OBJECTIVE: To investigate the potential benefit of early administration of high doses of Vitamin C in addition to standard of care in patients with sepsis or septic shock.

METHODS: This phase 3b multi-center trial is conducted in 8 hospitals throughout Belgium. In total 300 patients will be randomly assigned to one of two groups in a 1:1 allocation ratio. The intervention group will receive 1.5 g Vitamin C 4 times a day during 4 days, started within 6 hours after admission. The primary outcome is the average post-baseline patient SOFA score.

CONCLUSION: This trial will determine whether the early administration of Vitamin C in patients with sepsis or septic shock can lead to a more rapid solution of shock and less deterioration from sepsis to septic shock, hereby reducing morbidity and mortality as well as the length of hospital stay in this patient population.

TRIAL REGISTRATION: The C-EASIE trial has been registered on the ClinicalTrials.gov website on 10 February 2021 with registration number NCT04747795.

TRIAL SPONSOR: UZ Leuven (sponsor's reference S63213).

Conflict of interest statement

NO authors have competing interests.

References

  1. Chest. 2020 Jul;158(1):164-173 - PubMed
  2. Resuscitation. 2013 Apr;84(4):465-70 - PubMed
  3. Crit Care. 2015 Nov 27;19:418 - PubMed
  4. JAMA. 2016 Feb 23;315(8):801-10 - PubMed
  5. Eur J Emerg Med. 2021 Jun 1;28(3):189-195 - PubMed
  6. Am J Respir Crit Care Med. 2017 Apr 1;195(7):906-911 - PubMed
  7. J Res Pharm Pract. 2016 Apr-Jun;5(2):94-100 - PubMed
  8. Acute Crit Care. 2021 Aug;36(3):185-200 - PubMed
  9. Am J Clin Nutr. 1996 May;63(5):760-5 - PubMed
  10. Chest. 2017 Jun;151(6):1229-1238 - PubMed
  11. Curr Opin Crit Care. 2019 Aug;25(4):329-333 - PubMed
  12. Biofactors. 2009 Jan-Feb;35(1):5-13 - PubMed
  13. JAMA. 2019 Oct 1;322(13):1261-1270 - PubMed
  14. Intensive Care Med. 2020 Nov;46(11):2015-2025 - PubMed
  15. Crit Care Med. 2017 Mar;45(3):486-552 - PubMed
  16. JAMA. 2021 Feb 23;325(8):742-750 - PubMed
  17. BMC Med Res Methodol. 2011 Oct 26;11:144 - PubMed
  18. Antioxid Redox Signal. 2013 Dec 10;19(17):2068-83 - PubMed
  19. Pharmacol Ther. 2018 Sep;189:63-70 - PubMed
  20. JPEN J Parenter Enteral Nutr. 2014 Sep;38(7):825-39 - PubMed
  21. Crit Care. 2017 Dec 11;21(1):300 - PubMed
  22. FASEB J. 2003 Oct;17(13):1928-30 - PubMed
  23. Infect Dis (Lond). 2020 Apr;52(4):271-278 - PubMed
  24. Stat Med. 2003 Dec 15;22(23):3571-81 - PubMed
  25. JAMA. 2020 Aug 18;324(7):642-650 - PubMed
  26. Crit Care. 2014 Aug 06;18(4):460 - PubMed
  27. Chest. 2020 Jul;158(1):174-182 - PubMed
  28. J Transl Med. 2014 Jan 31;12:32 - PubMed
  29. JAMA. 2020 Feb 4;323(5):423-431 - PubMed

Publication Types