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

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ClinicalTrials.gov Identifier: NCT03540628
Recruitment Status : Recruiting
First Posted : May 30, 2018
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
Brittany Jesse Haines, Lakeland Health

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Septic Shock Dietary Supplement: Thiamine and Vitamin C Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Eligible patients will be randomized in equal blinded proportions by the pharmacy department to receive thiamine, vitamin C and hydrocortisone in the experimental arm or continue with hydrocortisone plus placebo and usual standard of care treatment as discussed previously.
Primary Purpose: Supportive Care
Official 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.
Actual Study Start Date : February 26, 2018
Estimated Primary Completion Date : February 26, 2020
Estimated Study Completion Date : February 26, 2020


Arm Intervention/treatment
No Intervention: Placebo Arm
The control arm of our randomized trial will receive a second pressor agent, hydrocortisone and standard of care to care for septic shock. The IV bags will be blinded by pharmacy. If the patient needs additional pressor support or therapy, the data will be recorded in the results.
Experimental: Thiamine and Vitamin C administration Arm
The experimental arm will receive a second pressor agent and hydrocortisone, plus thiamine and vitamin C along with the standard of care. The IV bags will be blinded by pharmacy. If the patient needs additional pressor support or therapy, the data will be recorded in the results.
Dietary Supplement: Thiamine and Vitamin C
Supplementary vitamins for the patient in septic shock




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion criteria include:

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

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): NCT03540628


Locations
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United States, Michigan
Lakeland Regional Healthcare Recruiting
Saint Joseph, Michigan, United States, 49085
Contact: Brittany J Haines, D.O, M.P.H    219-508-1370    bhaines1@lakelandhealth.org   
Contact: Michelino Mancini, DO, FAOECP    2699834081    mmancini@lakelandhealth.org   
Sponsors and Collaborators
Lakeland Health

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Responsible Party: Brittany Jesse Haines, Internal Medical Resident, Lakeland Health
ClinicalTrials.gov Identifier: NCT03540628     History of Changes
Other Study ID Numbers: MMMC#1576
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018
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

Additional relevant MeSH terms:
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Shock
Shock, Septic
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