Vitamin C, Steroids, and Thiamine, and Cerebral Autoregulation and Functional Outcome in Septic Shock

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study has been approved as a nested substudy of a multicenter trial (CORVICTES, Clinicaltrials.gov Identifier: NCT03592693). The current, randomized, placebo-controlled study will compare steroids/vitamin C versus placebo/placebo in septic shock, with respect to cerebral autoregulation, biomarkers, and functional outcome. The following hypotheses will be tested: The steroids/vitamin C/thiamine intervention may result in attenuation of the septic shock-associated impairment in cerebral autoregulation; and 2) The increased frequency of intact cerebral autoregulation in the intervention group may result in more neurologic failure free days and ventilator free days during a 60-day follow-up; improved survival to hospital discharge with good functional outcome; and better patient-reported health-related outcomes at 90-day follow-up.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Athens
• Treatments: Ascorbic Acid; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Thiamine; Vitamins

Criteria

Inclusion Criteria:

• Diagnosis of septic shock within 12 hours of admission to the intensive care unit (ICU).

Exclusion Criteria:

• Age < 18 years

• Pregnancy

• Patients with a fatal underlying disease who are unlikely to survive to hospital discharge

• Patients with acquired immunodeficiency and a CD4 count of < 50 / μL

• Patients with known glucose-6 phosphate dehydrogenase (G-6PD) deficiency.

• Patients with sepsis/septic shock transferred from another hospital

• Patients with features of sepsis/septic shock > 12 hours

• Patients who require treatment with corticosteroids for an indication other than sepsis

• Patients with any history of an allergic reaction