Thiamine, Vitamin C and Hydrocortisone in the Treatment of Septic Shock
NCT ID: NCT03540628
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
17 participants
INTERVENTIONAL
2018-02-26
2020-06-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
SUPPORTIVE_CARE
TRIPLE
Study Groups
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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.
No interventions assigned to this group
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.
Thiamine and Vitamin C
Supplementary vitamins for the patient in septic shock
Interventions
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Thiamine and Vitamin C
Supplementary vitamins for the patient in septic shock
Eligibility Criteria
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Inclusion Criteria
2. Age between 18-90 years old
3. Ability to provide written informed consent
Exclusion Criteria
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
18 Years
90 Years
ALL
No
Sponsors
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Spectrum Health - Lakeland
OTHER
Responsible Party
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Locations
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Lakeland Regional Healthcare
Saint Joseph, Michigan, United States
Countries
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Other Identifiers
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MMMC#1576
Identifier Type: -
Identifier Source: org_study_id