Septic Shock Clinical Trial
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.
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.
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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