TerminatedPhase 1/2

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

Stopped: Low rate of enrollment; publication of relevant results by other groups

Greece26 participantsStarted 2018-09-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Cerebral autoregulation

Timeframe: 24-78 hours after randomization

Cerebral blood flow

Timeframe: 24-78 hours after randomization

Trial details

NCT IDNCT03649633

SponsorUniversity of Athens

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-16