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Vitamin C, Hydrocortisone and Thiamine in Patients with Septic Shock (VITAMINS) trial: study protocol and statistical analysis plan.
Crit Care Resusc 2019; 21(2):119-125CC

Abstract

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.

Authors+Show Affiliations

Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia. Tomoko.Fujii@monash.edu.Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia.Department of Intensive Care, Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia.Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia.Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia.Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia.Department of Anaesthesia and Pain Medicine, Wellington Hospital, Capital and Coast District Health Board, Wellington, New Zealand.Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia.Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia.Critical Care and Perioperative Services, Monash Health, Monash University, Melbourne, VIC, Australia.Intensive Care Unit, Wellington Hospital, Capital and Coast District Health Board, Wellington, New Zealand.Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia.No affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

31142242

Citation

Fujii, Tomoko, et al. "Vitamin C, Hydrocortisone and Thiamine in Patients With Septic Shock (VITAMINS) Trial: Study Protocol and Statistical Analysis Plan." Critical Care and Resuscitation : Journal of the Australasian Academy of Critical Care Medicine, vol. 21, no. 2, 2019, pp. 119-125.
Fujii T, Udy AA, Deane AM, et al. Vitamin C, Hydrocortisone and Thiamine in Patients with Septic Shock (VITAMINS) trial: study protocol and statistical analysis plan. Crit Care Resusc. 2019;21(2):119-125.
Fujii, T., Udy, A. A., Deane, A. M., Luethi, N., Bailey, M., Eastwood, G. M., ... Bellomo, R. (2019). Vitamin C, Hydrocortisone and Thiamine in Patients with Septic Shock (VITAMINS) trial: study protocol and statistical analysis plan. Critical Care and Resuscitation : Journal of the Australasian Academy of Critical Care Medicine, 21(2), pp. 119-125.
Fujii T, et al. Vitamin C, Hydrocortisone and Thiamine in Patients With Septic Shock (VITAMINS) Trial: Study Protocol and Statistical Analysis Plan. Crit Care Resusc. 2019;21(2):119-125. PubMed PMID: 31142242.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Vitamin C, Hydrocortisone and Thiamine in Patients with Septic Shock (VITAMINS) trial: study protocol and statistical analysis plan. AU - Fujii,Tomoko, AU - Udy,Andrew A, AU - Deane,Adam M, AU - Luethi,Nora, AU - Bailey,Michael, AU - Eastwood,Glenn M, AU - Frei,Daniel, AU - French,Craig, AU - Orford,Neil, AU - Shehabi,Yahya, AU - Young,Paul J, AU - Bellomo,Rinaldo, AU - ,, PY - 2019/5/31/entrez PY - 2019/5/31/pubmed PY - 2019/6/5/medline SP - 119 EP - 125 JF - Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine JO - Crit Care Resusc VL - 21 IS - 2 N2 - 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. SN - 1441-2772 UR - https://www.unboundmedicine.com/medline/citation/31142242/Vitamin_C,_Hydrocortisone_and_Thiamine_in_Patients_with_Septic_Shock_(VITAMINS)_trial:_study_protocol_and_statistical_analysis_plan L2 - https://ClinicalTrials.gov/search/term=31142242 [PUBMED-IDS] DB - PRIME DP - Unbound Medicine ER -