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

Phase 3CompletedNCT03872011

Northern Jiangsu People's Hospital408 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

408

Conditions

Septic Shock

Interventions

Vitamin C,thiamine,hydrocortisoneDRUG

Vitamin C (2g) will be diluted in 100ml 0.9%NACL and administered ivd every 6 hours for 5 days or until participant is discharged from the ICU. Thiamine(200mg) will be diluted in 100ml 0.9%NACL and administered ivd every 12 hours for 5 days or until participant is discharged from the ICU. Hydrocortisone was administered 200 mg/d as a continuous infusion for 5 days or until participant is discharged from the ICU.

PlaceboDRUG

Normal saline (0.9% NaCl solution) volume to match all components

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Northern Jiangsu Province people's hospital

Yangzhou, Jiangsu, China

Outcomes

Primary Outcomes

90-day mortality

Death from any cause at 90 days after the onset of septic shock

Time frame: 90 days after randomization

Secondary Outcomes

ICU mortality

All-cause mortality at ICU discharge

Time frame: 90 days after randomization

Hospital mortality

All-cause mortality at hospital discharge

Time frame: 90 days after randomization

28-day mortality

Death from any cause at 28 days after the onset of septic shock

Time frame: 28 days after randomization

Data from ClinicalTrials.gov

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