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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
Sponsor:
Information provided by (Responsible Party):
Qing-quan Lv, Northern Jiangsu Province People's Hospital

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.

Condition or disease Intervention/treatment Phase
Septic Shock Drug: Vitamin C,thiamine,hydrocortisone Drug: Placebo Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 406 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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.

Other Names:
  • Ascorbic Acid
  • Vitamin B1

Placebo Comparator: Placebo
Normal Saline Solution (0.9%NaCl) in a volume to match all experimental arm components
Drug: Placebo
Normal saline (0.9% NaCl solution) volume to match all components
Other Name: Normal saline




Primary Outcome Measures :
  1. 90-day mortality [ Time Frame: 90 days after randomization ]
    Death from any cause at 90 days after the onset of septic shock


Secondary Outcome Measures :
  1. ICU mortality [ Time Frame: 90 days after randomization ]
    All-cause mortality at ICU discharge

  2. Hospital mortality [ Time Frame: 90 days after randomization ]
    All-cause mortality at hospital discharge

  3. 28-day mortality [ Time Frame: 28 days after randomization ]
    Death from any cause at 28 days after the onset of septic shock



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Qingquan Lyu, Master 0086-18051063899 bonhomie2014@163.com
Contact: Xiaohua Gu, Master 0086-18051062325 njguxiaohua@163.com

Locations
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China, Jiangsu
Northern Jiangsu Province people's hospital Recruiting
Yangzhou, Jiangsu, China, 225000
Contact: Qingquan Lyu, Master    0086-18051063899    bonhomie2014@163.com   
Contact: Xiaohua Gu, Master    0086-18051062325    njguxiaohua@163.com   
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         
Sponsors and Collaborators
Northern Jiangsu Province People's Hospital
Investigators
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Principal Investigator: Qingquan Lyu, Master Northern Jiangsu Province People's Hospital

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Responsible Party: Qing-quan Lv, Principal Investigator, Northern Jiangsu Province People's Hospital
ClinicalTrials.gov Identifier: NCT03872011     History of Changes
Other Study ID Numbers: 2019KY-145
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Qing-quan Lv, Northern Jiangsu Province People's Hospital:
septic shock
vitamin C
thiamine
hydrocortisone
mortality
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Vitamins
Ascorbic Acid
Thiamine
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anti-Inflammatory Agents
Vitamin B Complex