Vitamin C, Hydrocortisone and Thiamine for Septic Shock
Status:
Recruiting
Trial end date:
2021-09-01
Target enrollment:
Participant gender:
Summary
Prior data has shown that both corticosteroids and vitamin C reduce the activation of nuclear
factor ƘB (NFƘB), thereby ultimately attenuating the systemic inflammatory response to
sepsis/septic shock and augmenting the responsiveness to vasopressors. Therefore, the current
investigators hypothesized that the combined use of vitamin C and stress-dose hydrocortisone
may improve the outcomes of patients with septic shock. The investigators intend to perform a
randomized, multicenter, parallel group, double-blind, placebo-controlled trial of vitamin C
plus stress-dose hydrocortisone or placebo plus placebo for a total of four days after
randomization of patients fulfilling the current consensus criteria for septic shock. The
primary outcome will be hospital mortality, whereas the scondary outcomes will include
60-day, 28-day mortality, time to vasopressor cessation, procalcitonin clearance and change
in the Sequential Organ Failure Assessment score over the first 4 days after randomization,
neurologic failure-free days, and length of stay in the intensive care unit (ICU) and the
hospital. Target enrollment will be 400 patients.
Phase:
Phase 2
Details
Lead Sponsor:
University of Athens
Collaborators:
General Hospital of Nikaia "Saint Panteleimon" General Hospital of Nikaia “Saint Panteleimon” Naval Hospital, Athens