Vitamin C, Hydrocortisone and Thiamine in Patients with Septic Shock (VITAMINS) trial: study protocol and statistical analysis plan.

Fujii, Tomoko; Udy, Andrew A; Deane, Adam M; Luethi, Nora; Bailey, Michael; Eastwood, Glenn M; Frei, Daniel; French, Craig; Orford, Neil; Shehabi, Yahya; Young, Paul J; Bellomo, Rinaldo (2019). Vitamin C, Hydrocortisone and Thiamine in Patients with Septic Shock (VITAMINS) trial: study protocol and statistical analysis plan. Critical care and resuscitation, 21(2), pp. 119-125. College of Intensive Care Medicine of Australia and New Zealand

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BACKGROUND

Septic shock is associated with poor outcomes. Vitamin C (ascorbic acid) is a cellular antioxidant and has anti-inflammatory properties. Whether the combination therapy of vitamin C, thiamine and hydrocortisone reduces vasopressor dependency in septic shock is unclear.

OBJECTIVES

To describe the protocol and statistical analysis plan of a multicentre, open-label, prospective, phase 2 randomised clinical trial evaluating the effects of vitamin C, thiamine and hydrocortisone when compared with hydrocortisone monotherapy on the duration of vasopressor administration in critically ill patients with septic shock.

METHODS

VITAMINS is a multicentre cardiovascular efficacy trial in adult patients with septic shock. Randomisation occurs via a secure website with stratification by site, and allocation concealment is maintained throughout the trial. The primary outcome is the duration of time alive and free of vasopressor administration at Day 7. Secondary outcomes include feasibility endpoints and some patientcentred outcomes. All analyses will be conducted on an intention-to-treat basis.

CONCLUSION

The VITAMINS trial will determine whether combination therapy of vitamin C, thiamine and hydrocortisone when compared with hydrocortisone increases vasopressor-free hours in critically ill patients with septic shock. The conduct of this study will provide important information on the feasibility of studying this intervention in a phase 3 trial.

TRIAL REGISTRATION

ClinicalTrials.gov, identification No. NCT03333278.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Clinic of Medical Oncology

UniBE Contributor:

Lüthi, Nora

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1441-2772

Publisher:

College of Intensive Care Medicine of Australia and New Zealand

Language:

English

Submitter:

Rebeka Gerber

Date Deposited:

22 Jan 2020 08:10

Last Modified:

05 Dec 2022 15:35

PubMed ID:

31142242

BORIS DOI:

10.7892/boris.138511

URI:

https://boris.unibe.ch/id/eprint/138511

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