A Phase 3 interventional study of Vitamin C,thiamine,hydrocortisone and Placebo in Septic Shock, sponsored by Northern Jiangsu People's Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-23.
Sponsored by Northern Jiangsu People's Hospital · Phase 3, Interventional, and Treatment
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.
862 studies on the registry are indexed under Shock, Septic; 207 are open to participants now.
This study's enrollment of 408 is above the median of 80 across 530 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →Northern Jiangsu People's Hospital is the lead sponsor of 60 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: Vitamin C,thiamine,hydrocortisone
Normal Saline Solution (0.9%NaCl) in a volume to match all experimental arm components
Drug: Placebo
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.
Also known as: Ascorbic Acid, Vitamin B1
Normal saline (0.9% NaCl solution) volume to match all components
Also known as: Normal saline
90-day mortality
Death from any cause at 90 days after the onset of septic shock
Time frame: 90 days after randomization
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
Plan to share: No
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Northern Jiangsu People's Hospital