Vitamin C, Thiamine and Hydrocortisone for the Treatment of Septic Shock

Northern Jiangsu People's Hospital

Status and phase: Completed; Phase 3

Conditions: Septic Shock

Treatments: Drug: Placebo; Drug: Vitamin C,thiamine,hydrocortisone

Study type: Interventional

Funder types: Other

Identifiers

NCT03872011

2019KY-145

Details and patient eligibility

About

The purpose of this study is to determine whether the combination therapy (vitamin C,thiamine and hydrocortisone) is effective in the treatment of septic shock.

Full description

Septic Shock is a leading cause of morbidity and mortality in critically ill patients worldwide.

A potential benefit of vitamin C with thiamine and low-dose hydrocortisone in the treatment of septic shock has recently been described(PMID 27940189) . The patients with septic shock who received this combination of medications weaned off pressors earlier, suffered less organ failure, and had improved mortality. The doses of vitamin C used in this trial are high, yet seemed to be safe and can be considered for use.

In this randomized controlled trial, we aim to evaluate the effect of the combination therapy (vitamin C,thiamine and hydrocortisone) on septic shock.

Enrollment: 408 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 years old or older
• Onset of septic shock within 12 hours

Exclusion criteria

• Systemic corticosteroid therapy within the last 3 months before septic shock
• High-dose steroid therapy
• Immunosuppression
• Pregnant
• Known glucose-6 phosphate dehydrogenase (G-6PD) deficiency
• Known hemachromatosis
• Known allergy to vitamin C, hydrocortisone, or thiamine
• Anticipated death from a preexisting disease within 90 days after randomization (as determined by the enrolling physician)
• Refusal of the attending staff or patient family

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

408 participants in 2 patient groups, including a placebo group

Vitamin C,thiamine,hydrocortisone

Experimental group

Description:

The combination of vitamin C, thiamine, hydrocortisone : Vitamin C 2g every 6 hours x 5-days Thiamine 200mg every 12 hours x 5-days Hydrocortisone 200mg as a continuous infusion x 5-days

Treatment:

Drug: Vitamin C,thiamine,hydrocortisone

Placebo

Placebo Comparator group

Description:

Normal Saline Solution (0.9%NaCl) in a volume to match all experimental arm components

Treatment:

Drug: Placebo