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

Phase 3

Completed

• Conditions: Septic Shock
• Interventions: Drug: Placebo; Drug: Vitamin C,thiamine,hydrocortisone

• Registration Number: NCT03872011
• Lead Sponsor: Northern Jiangsu People's Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2019-02-19
• Study First Submitted: 2019-03-04
• Study First Submitted QC: 2019-03-09
• Study First Posted: 2019-03-12
• Status Verified: 2021-09
• Primary Completion: 2021-09-20
• Study Completion: 2021-09-20
• Last Update Submitted: 2021-09-21
• Last Update Posted: 2021-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 408

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Normal Saline Solution (0.9%NaCl) in a volume to match all experimental arm components
Vitamin C,thiamine,hydrocortisone	Vitamin C,thiamine,hydrocortisone	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

Primary Outcome Measures

Name	Time	Method
90-day mortality	90 days after randomization	Death from any cause at 90 days after the onset of septic shock

Secondary Outcome Measures

Name	Time	Method
28-day mortality	28 days after randomization	Death from any cause at 28 days after the onset of septic shock
Hospital mortality	90 days after randomization	All-cause mortality at hospital discharge
ICU mortality	90 days after randomization	All-cause mortality at ICU discharge

Trial Locations

Locations (1)

Northern Jiangsu Province people's hospital; 🇨🇳 Yangzhou, Jiangsu, China