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NCT Number: NCT03540628

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

The purpose of this research study is to determine whether patients who receive thiamine (vitamin B1), vitamin C and hydrocortisone while in septic shock have improved outcomes compared to hydrocortisone alone.

A recently published article "Hydrocortisone, Vitamin C and Thiamine for the treatment of Severe Sepsis and Septic Shock," suggested substantial mortality reduction (78%). We wish to test the hypothesis that mortality reduction is at least 25% in a prospective randomized trial. Other important sub-aims include the testing whether the protocol reduces the time on pressors agents, reduces the trajectory of the SOFA score, or reduces the trajectory of procalcitonin.

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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–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lakeland Regional Healthcare

Saint Joseph, Michigan, 49085, United States

About this study

The study has four specific aims. The first is to utilize the Marik protocol published in CHEST to determine mortality reduction in septic shock with thiamine (vitamin B1), vitamin C and hydrocortisone supplementation. The second aim is to determine whether supplementation with thiamine, vitamin C and hydrocortisone reduce time spent on vasopressor support. Thirdly, whether the trajectory of the SOFA score is affected by supplementation with thiamine, hydrocortisone and vitamin C. Fourthly, assess the trajectory of procalcitonin, a laboratory test, in patients treated with the protocol.

This is a single center community based hospital in Southwest Michigan, investigator blinded, randomized placebo controlled trial, 24 month, parallel group, two arm, superiority study with a 1:1 allocation ratio to compare the efficacy of thiamine, vitamin C and hydrocortisone in the treatment of severe sepsis and septic shock. Each arm of the research study will contain 30 patients in order to detect a 25% mortality reduction. Enrollment for this study will be initiated in patients with septic shock that require addition of a second pressor agent. The control arm of our randomized trial will receive a second pressor agent, hydrocortisone and standard of care. If the patient needs additional pressor support or therapy, that will be recorded in the results.

The experimental arm will receive a second pressor agent and hydrocortisone, plus thiamine and vitamin C along with the standard of care. If the patient needs additional pressor support or therapy that will be recorded in the results.

To clarify, both arms will utilize two vasopressor agents, hydrocortisone and supportive care, the experimental group will also receive vitamin C and thiamine.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of Septic Shock on two vasopressor agents
  • Age between 18-90 years old
  • Ability to provide written informed consent

Exclusion criteria

include:

  • Age younger than 18 years old
  • Pregnancy
  • DNR or DNI status with limitations of care, such as "supportive care only"
  • Patients/advocates that request thiamine, vitamin C or hydrocortisone supplementation

Treatment and study plan

Thiamine and Vitamin C

Dietary Supplement

Supplementary vitamins for the patient in septic shock

Primary outcomes

  1. The mortality rate comparison of patients with septic shock at Lakeland Regional Medical Center to the study published in CHEST.

    Time frame: 24 months

    The mortality rate difference between control and experimental arms

Secondary outcomes

  1. The duration on vasopressor support

    Time frame: 24 months

    Control and Experimental arms will quantify the time requiring vasopressor therapy.

  2. Quantify the Sequential Organ Failure Assessment score in Septic shock patients requiring vasopressor therapy

    Time frame: 24 months

    Control and experimental arms with both calculate daily Sequential Organ Failure Assessment scores to assess for differences.

Sponsors and collaborators

Lead sponsor

Corewell Health South

Other

Registry information

Official study title

A Single Center, Investigator Blinded, Randomized Placebo Control, 24 Month, Parallel Group, Superiority Study to Compare the Efficacy of Thiamine, Vitamin C and Hydrocortisone in the Treatment of Septic Shock.

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 30, 2018
Registry last updated
Dec 9, 2024

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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