Vitamin C, Thiamine and Hydrocortisone for the Treatment of Septic Shock
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|ClinicalTrials.gov Identifier: NCT03872011|
Recruitment Status : Recruiting
First Posted : March 12, 2019
Last Update Posted : March 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Septic Shock||Drug: Vitamin C,thiamine,hydrocortisone Drug: Placebo||Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||406 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Initiation of Vitamin C, Thiamine and Hydrocortisone Therapy for Septic Shock in Adults: A Randomized Clinical Trial|
|Actual Study Start Date :||February 19, 2019|
|Estimated Primary Completion Date :||May 1, 2020|
|Estimated Study Completion Date :||August 1, 2020|
Experimental: 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
Drug: Vitamin 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.
Placebo Comparator: Placebo
Normal Saline Solution (0.9%NaCl) in a volume to match all experimental arm components
Normal saline (0.9% NaCl solution) volume to match all components
Other Name: Normal saline
- 90-day mortality [ Time Frame: 90 days after randomization ]Death from any cause at 90 days after the onset of septic shock
- ICU mortality [ Time Frame: 90 days after randomization ]All-cause mortality at ICU discharge
- Hospital mortality [ Time Frame: 90 days after randomization ]All-cause mortality at hospital discharge
- 28-day mortality [ Time Frame: 28 days after randomization ]Death from any cause at 28 days after the onset of septic shock
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872011
|Contact: Qingquan Lyu, Masteremail@example.com|
|Contact: Xiaohua Gu, Masterfirstname.lastname@example.org|
|Northern Jiangsu Province people's hospital||Recruiting|
|Yangzhou, Jiangsu, China, 225000|
|Contact: Qingquan Lyu, Master 0086-18051063899 email@example.com|
|Contact: Xiaohua Gu, Master 0086-18051062325 firstname.lastname@example.org|
|Principal Investigator: Qingquan Lyu, Master|
|Sub-Investigator: Xiaohua Gu, Master|
|Sub-Investigator: Ruiqiang Zheng, Bachelor|
|Sub-Investigator: Qihong Chen, Doctor|
|Sub-Investigator: Fengdi Yan, Doctor|
|Sub-Investigator: Jiangquan Yu, Master|
|Principal Investigator:||Qingquan Lyu, Master||Northern Jiangsu Province People's Hospital|