The Vitamin C, Hydrocortisone and Thiamine in Patients With Septic Shock Trial

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.

Conditions

• Shock, Septic
• Critically Ill
• Vasoplegic Syndrome
• Sepsis

Interventions

DRUG

Vitamin C

Ascorbic acid 1.5g every 6 hours i.v. while in ICU, until shock resolution for a maximum of ten days

DRUG

Thiamine

Thiamine 200mg every 12 hours i.v. while in ICU, until shock resolution for a maximum of ten days

DRUG

Hydrocortisone,

Hydrocortisone 50mg every 6 hours i.v while in ICU, until shock resolution or for a maximum of 7 days, then tapered or stopped.

Sponsors & Collaborators

• Austin Hospital, Melbourne Australia

  collaborator OTHER

• Melbourne Health

  collaborator OTHER

• Barwon Health

  collaborator OTHER_GOV

• Monash Health

  collaborator OTHER

• The Alfred

  collaborator OTHER

• Wellington Hospital

  collaborator OTHER_GOV

• Western Health, Australia

  collaborator OTHER_GOV

• Australian and New Zealand Intensive Care Research Centre

  lead OTHER

Principal Investigators

• Rinaldo Bellomo, Professor · Austin Hospital, Melbourne Australia

• Nora Luethi, MD · ANZIC-RC

• Tomoko Fujii, MD · ANZIC-RC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-05-02

Primary Completion

2019-07-16

Completion

2019-10-06

Countries

• Australia
• Brazil
• New Zealand

Study Locations