NCT03872011

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

Initiation of Vitamin C, Thiamine and Hydrocortisone Therapy for Septic Shock in Adults: A Randomized Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 408 (actual)
• Sponsor: Northern Jiangsu People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Septic Shock

Interventions

Type	Name	Description
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.
DRUG	Placebo	Normal saline (0.9% NaCl solution) volume to match all components

Timeline

• Start date: 2019-02-19
• Primary completion: 2021-09-20
• Completion: 2021-09-20
• First posted: 2019-03-12
• Last updated: 2021-09-23

Locations

1 site across 1 country: China