Metabolic Resuscitation Using Ascorbic Acid, Thiamine, and Glucocorticoids in Sepsis.

Completed · Phase 2 · Has a placebo group

Conditions studied: Sepsis, Severe, Septic Shock

In brief

This study has been created to compare the addition of intravenous (IV) vitamin C, thiamine, and hydrocortisone to the usual standard of care of sepsis and septic shock. Sepsis is a possibly life-threatening condition in which a patient may have organ dysfunction due to an infection. Septic shock is defined as low blood pressure and organ dysfunction that do not improve after administering IV fluids. Standard of care for sepsis and septic shock include early administration of IV antibiotics, IV fluids, and vasopressors if need be to provide oxygen to vital organs. A large amount of experimental data has shown that vitamin C and corticosteroids decrease the release of inflammatory substances which may lead to organ failure seen in sepsis. Vitamin C and corticosteroids also improve blood flow to vital organs and increase the body's ability to respond well to vasopressor medications used in septic shock. Low blood levels of both thiamine and vitamin C are common in sepsis. The study will be placebo controlled, meaning one group will receive vitamin C, thiamine, and hydrocortisone, and the other will receive an inactive substance ("placebo"). The goal of the study is to compare the effects of receiving vitamin C, thiamine, and hydrocortisone (along with the standard sepsis care) versus placebo and standard sepsis care.

Key facts

Study ID

NCT03422159

Run by

Community Medical Center, Toms River, NJ

People needed

140

Starts

2018-02-05

Expected to finish

2019-08-27

Last updated by the study team

2021-09-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• i. Diagnosis of sepsis or septic shock within 12 hours of admission to the ICU ii. Informed consent as dictated by IRB and local practice. iii. Compliance with the 3 hour sepsis bundle
• 30ml/kg of intravenous crystalloid fluid (e.g.: sodium chloride 0.9%) for lactic acid >4 and/or systolic blood pressure <90mmHg / mean arterial pressure <65mmHg
• Lactic acid level drawn
• Broad spectrum antibiotics given after obtaining blood cultures

You may not qualify if…

• i. Age < 18 years ii. Pregnant iii. DNR/DNI with limitations of care on admission iv. Patients with terminal end stage disease (i.e. stage IV cancer, end stage heart failure) that are unlikely to survive to hospital discharge v. Patients with a primary admitting diagnosis of an acute cerebral vascular event, acute coronary syndrome, active gastrointestinal bleeding, burn or trauma [64-66] vi. Requirement for immediate surgery [64-66] vii. Patients with HIV and a CD4 < 50 mm2 [64-66] viii. Patients with known glucose-6 phosphate dehydrogenase (G-6PD) deficiency.[39] ix. Patients with sepsis/septic shock transferred from another hospital x. Patients with features of sepsis/septic shock > 24 hours after admission

Where it is running

• Monmouth Medical Center, Southern Campus — Lakewood, New Jersey, United States
• Community Medical Center — Toms River, New Jersey, United States

Full record on ClinicalTrials.gov

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