Status:
TERMINATED
Effect of IV Vitamin C, Thiamine, and Steroids on Mortality of Septic Shock
Lead Sponsor:
New York Presbyterian Brooklyn Methodist Hospital
Conditions:
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Preliminary studies show that giving a "cocktail" of intravenous vitamin C, vitamin B1, and steroids to critically ill patients with septic shock may dramatically improve mortality in those patients. ...
Detailed Description
This is a double-blind randomized placebo controlled study. Only the dispensing pharmacist, who has no clinical interaction with the patient and is not part of the bedside treatment team, will be awar...
Eligibility Criteria
Inclusion
- Patients admitted to medical intensive care unit (MICU) for less than 24 hours, who are hypotensive despite a fluid bolus of 30 mL/kg and who are requiring pressors to keep MAP \> 65 of at least 5 mcg/min of levophed or equivalent and whose shock is clinically suspected to be secondary to sepsis.
- In addition, stress dose corticosteroids, hydrocortisone 50mg IV Q6hrs, will have to have been started or intended to be started.
Exclusion
- Contraindication to corticosteroids, thiamine, or vitamin C
- Treating physician opposed to administering corticosteroids to the patient
- Age \< 18 years
- Pregnancy
- DNR/DNI/limitations of care
- Patients with a fatal underlying disease who are unlikely to survive to hospital discharge
- Patients with a primary admitting diagnosis of an acute cerebral vascular event, acute coronary syndrome, active gastrointestinal bleeding, burn or trauma
- Requirement for immediate surgery
- Patients with HIV and a CD4 \< 50 mm2
- Patients with known glucose-6 phosphate dehydrogenase (G-6PD) deficiency.8
- Involvement in another clinical trial
Key Trial Info
Start Date :
October 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 4 2020
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03828929
Start Date
October 15 2019
End Date
February 4 2020
Last Update
February 10 2020
Active Locations (1)
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1
New York Methodist Hospital
Brooklyn, New York, United States, 11215