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NCT Number: NCT03872011

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Northern Jiangsu Province people's hospital

Yangzhou, Jiangsu, 225000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Ascorbic Acid, Vitamin B1

Placebo

Drug

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

Other names: Normal saline

Primary outcomes

  1. 90-day mortality

    Time frame: 90 days after randomization

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Northern Jiangsu People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 12, 2019
Registry last updated
Sep 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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