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

Primary Purpose

Septic Shock

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Vitamin C,thiamine,hydrocortisone
Placebo
Sponsored by
Northern Jiangsu Province People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring septic shock, vitamin C, thiamine, hydrocortisone, mortality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northern Jiangsu Province people's hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin C,thiamine,hydrocortisone

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

ICU mortality
All-cause mortality at ICU discharge
Hospital mortality
All-cause mortality at hospital discharge
28-day mortality
Death from any cause at 28 days after the onset of septic shock

Full Information

First Posted
March 4, 2019
Last Updated
September 21, 2021
Sponsor
Northern Jiangsu Province People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03872011
Brief Title
Vitamin C, Thiamine and Hydrocortisone for the Treatment of Septic Shock
Official Title
Initiation of Vitamin C, Thiamine and Hydrocortisone Therapy for Septic Shock in Adults: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 19, 2019 (Actual)
Primary Completion Date
September 20, 2021 (Actual)
Study Completion Date
September 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northern Jiangsu Province People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
septic shock, vitamin C, thiamine, hydrocortisone, mortality

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
408 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin C,thiamine,hydrocortisone
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal Saline Solution (0.9%NaCl) in a volume to match all experimental arm components
Intervention Type
Drug
Intervention Name(s)
Vitamin C,thiamine,hydrocortisone
Other Intervention Name(s)
Ascorbic Acid, Vitamin B1
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal saline
Intervention Description
Normal saline (0.9% NaCl solution) volume to match all components
Primary Outcome Measure Information:
Title
90-day mortality
Description
Death from any cause at 90 days after the onset of septic shock
Time Frame
90 days after randomization
Secondary Outcome Measure Information:
Title
ICU mortality
Description
All-cause mortality at ICU discharge
Time Frame
90 days after randomization
Title
Hospital mortality
Description
All-cause mortality at hospital discharge
Time Frame
90 days after randomization
Title
28-day mortality
Description
Death from any cause at 28 days after the onset of septic shock
Time Frame
28 days after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qingquan Lyu, Master
Organizational Affiliation
Northern Jiangsu Province People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northern Jiangsu Province people's hospital
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36171582
Citation
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.
Results Reference
derived

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

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