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

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03872011
• Other study ID #: 2019KY-145
• Status: Completed
• Phase: Phase 3
• Start date: February 19, 2019
• Est. completion date: September 20, 2021

Study information

• Verified date: September 2021
• Source: Northern Jiangsu Province People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 408
• Est. completion date: September 20, 2021
• Est. primary completion date: September 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

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

Locations

Country	Name	City	State
China	Northern Jiangsu Province people's hospital	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Northern Jiangsu Province People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	90-day mortality	Death from any cause at 90 days after the onset of septic shock	90 days after randomization
Secondary	ICU mortality	All-cause mortality at ICU discharge	90 days after randomization
Secondary	Hospital mortality	All-cause mortality at hospital discharge	90 days after randomization
Secondary	28-day mortality	Death from any cause at 28 days after the onset of septic shock	28 days after randomization