Septic Shock
Conditions
Keywords
septic shock, vitamin C, thiamine, hydrocortisone, mortality
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.
Interventions
DRUGVitamin C,thiamine,hydrocortisone
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.
DRUGPlacebo
Normal saline (0.9% NaCl solution) volume to match all components
Sponsors
Northern Jiangsu People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 90-day mortality | 90 days after randomization | Death from any cause at 90 days after the onset of septic shock |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital mortality | 90 days after randomization | All-cause mortality at hospital discharge |
| 28-day mortality | 28 days after randomization | Death from any cause at 28 days after the onset of septic shock |
| ICU mortality | 90 days after randomization | All-cause mortality at ICU discharge |
Countries
China
Outcome results
None listed