The Vitamin C, Hydrocortisone and Thiamine in Patients With Septic Shock Trial
Status:
Completed
Trial end date:
2019-10-06
Target enrollment:
Participant gender:
Summary
Sepsis has been characterised as a dysregulated host response to infection. Adjunctive
therapies targeting the inflammatory cascade are being increasingly explored, although to
date, have failed to demonstrate consistent benefit, and sepsis continues to manifest poor
outcomes. Hospital mortality in patients with septic shock remains as high as 22% in
Australia and New Zealand. From a global perspective, 31 million sepsis and 19 million severe
sepsis cases are expected to be treated in hospitals all over the world per year.
To date, experimental data have reported that both high dose intravenous vitamin C and
corticosteroids attenuate the acceleration of the inflammatory cascade and possibly reduce
the endothelial injury characteristic of sepsis, enhance the release of endogenous
catecholamines and improve vasopressor responsiveness.
Therefore, the investigators plan to conduct a feasibility pilot prospective, multi-centre,
randomised, open-label, trial in ICU patients with septic shock to test whether the
intravenous administration of high dose Vitamin C (6g/d), Thiamine (400mg/d) and
Hydrocortisone (200mg/d) leads to a more rapid resolution shock and vasopressor dependence.
Phase:
Phase 2
Details
Lead Sponsor:
Australian and New Zealand Intensive Care Research Centre
Collaborators:
Austin Hospital, Melbourne Australia Barwon Health Melbourne Health Monash Health Monash Medical Centre St Vincent's Hospital Melbourne The Alfred Wellington Hospital Western Health, Australia