Effect of IV Vitamin C, Thiamine, and Steroids on Mortality of Septic Shock

• Status: Terminated
• Trial end date: 2020-02-04
• Target enrollment: 0
• Participant gender: All

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. These studies suffer from inadequate design due to lack of controls and blinding to prove the causal effect. Our goal is to conduct a prospective blinded randomized control trial to investigate whether this intervention truly effect outcomes.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York Methodist Hospital; New York Presbyterian Brooklyn Methodist Hospital
• Treatments: Ascorbic Acid; Thiamine; Vitamins

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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