drugset / Trial / NCT03649633

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

NCT03649633

Phase 1/2 Terminated 26 enrolled University of Athens
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2018-09-06
Primary completion
2023-01-16
Completion
2023-01-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydrocortisone Other / unclassified 200 mg
Subject Vitamin C Other / unclassified 1500 mg