NCT04796636: HIGH-VIS

High-dose Intravenous Vitamin C in Patients With Septic Shock

Status unknown Phase 1 Last updated 4 November 2022

What this trial tests

Phase 1 trial testing Sodium Ascorbate in Sepsis, Severe in 30 participants. Status unknown.

Timeline

27 September 2021

Primary endpoint
22 September 2023

22 December 2023

Quick facts

Lead sponsor	Melbourne Health
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	27 September 2021
Primary completion	22 September 2023
Estimated completion	22 December 2023
Sites	1 location across Australia

Drugs / interventions tested

• Sodium Ascorbate — full drug profile →

Conditions studied

• Sepsis, Severe — all drugs for Sepsis, Severe →
• Septic Shock — all drugs for Septic Shock →

Sponsor

Melbourne Health — full company profile →

Who can join

Adults 18 to 80, any sex, with Sepsis, Severe or Septic Shock. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Despite promising observational and phase 1 data, the therapeutic potential of vitamin C for the management of septic shock has not borne out in recent large multi-centre randomized controlled trials. There is biological plausibility for benefit with intravenous vitamin C, and the investigators hypothesize that the doses used in these trials were insufficient to demonstrate an effect. High-dose vitamin C has been trialed in patients with cancer and burns and proven to be safe. The investigators have recently demonstrated a dramatic benefit of high-dose intravenous vitamin C in reversing organ dysfunction in a large mammalian model of sepsis. The proposed prospective interventional study will be the first to administer high-dose intravenous vitamin C in critically ill patients with sepsis. The objectives of this study will be to determine whether high-dose intravenous vitamin C (i) reduces vasopressor requirement in critically ill patients with septic shock (ii) reverses organ dysfunction and (iii) is well tolerated.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting Oxidative Stress in Septic Acute Kidney Injury: From Theory to Practice.
   Ow CPC, Trask-Marino A, Betrie AH, Evans RG, et al · · 2021 · cited 45× · PMID 34501245 · DOI 10.3390/jcm10173798
2. Therapeutic potential of megadose vitamin C to reverse organ dysfunction in sepsis and COVID-19.
   May CN, Bellomo R, Lankadeva YR. · · 2021 · cited 26× · PMID 34061355 · DOI 10.1111/bph.15579
3. A neutrophil elastase inhibitor, sivelestat, attenuates sepsis-induced acute kidney injury by inhibiting oxidative stress.
   Zhu W, Ou Y, Wang C, An R, et al · · 2024 · cited 4× · PMID 38638960 · DOI 10.1016/j.heliyon.2024.e29366