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

NCT03872011 | Completed Phase 3

• 1 other identifier: 2019KY-145
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Keywords

septic shock; vitamin C; thiamine; hydrocortisone; mortality

Outcome Measures

Primary Outcomes (1)

• 90-day mortality

  Death from any cause at 90 days after the onset of septic shock

  90 days after randomization

Secondary Outcomes (3)

• ICU mortality

  90 days after randomization

• Hospital mortality

  90 days after randomization

• 28-day mortality

  28 days after randomization

Study Arms (2)

Vitamin C,thiamine,hydrocortisone

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Normal Saline Solution (0.9%NaCl) in a volume to match all experimental arm components

Drug: Placebo

Interventions

Vitamin C,thiamine,hydrocortisone DRUG

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

Vitamin C,thiamine,hydrocortisone

Placebo DRUG

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

Also known as: Normal saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years old or older
• Onset of septic shock within 12 hours

You may not qualify if:

• 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

Sponsors & Collaborators

• Northern Jiangsu People's Hospital: lead

Study Sites (1)

Northern Jiangsu Province people's hospital

Yangzhou, Jiangsu, 225000, China

Location

Related Publications (1)

• Lyu QQ, Zheng RQ, Chen QH, Yu JQ, Shao J, Gu XH. Early administration of hydrocortisone, vitamin C, and thiamine in adult patients with septic shock: a randomized controlled clinical trial. Crit Care. 2022 Sep 28;26(1):295. doi: 10.1186/s13054-022-04175-x.

  PMID: 36171582 DERIVED

MeSH Terms

Conditions

Shock, Septic

Interventions

Hydrocortisone; Ascorbic Acid; Thiamine; Saline Solution

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Qingquan Lyu, Master

  Northern Jiangsu People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 12, 2019
• Study Start: February 19, 2019
• Primary Completion: September 20, 2021
• Study Completion: September 20, 2021
• Last Updated: September 23, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)