HIGH-dose Intravenous VItamin C in Patients With Septic Shock: HIGH-VIS Trial

Who is this study for? Patients with Septic Shock
What treatments are being studied? Sodium Ascorbate
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: No
View:

• Diagnosis of septic shock within 24 hours of admission to the ICU

• Age 18 - 80 years

• Presence of a central venous catheter for vasopressor infusion

• Presence of an arterial line to monitor blood pressure

• Definition of sepsis Suspected or documented infection and an increase of ≥ 2 SOFA points consequent to the infection.

• Definition of septic shock Sepsis AND an arterial lactate >2 mmol/L AND need for vasopressor therapy to keep MAP >65 mmHg for > 2 hours despite fluid resuscitation therapy.

Locations
Other Locations
Australia
Intensive Care Unit Royal Melbourne Hospital
Recruiting
Melbourne
Contact Information
Primary
Mark P Plummer, PhD
mark.plummer@mh.org.au
+61 419708399
Backup
Adam M Deane, PhD
adam.deane@mh.org.au
+61 431967560
Time Frame
Start Date: September 27, 2021
Estimated Completion Date: December 22, 2023
Participants
Target number of participants: 30
Treatments
Experimental: Intermediate dose
Sodium ascorbate (vitamin C) is provided by the manufacturer (Orthomolecular Medisearch Laboratory P/L, Braeside, Victoria, Australia) as 30 grams in 100 ml.~30 gram load over 2 hours (T = 0 - 2 hours)~30 gram infusion over 6 hours (T = 2-8 hours) which will be repeated at 14, 26 and 38 hours
Experimental: High dose
Sodium ascorbate (vitamin C) is provided by the manufacturer (Orthomolecular Medisearch Laboratory P/L, Braeside, Victoria, Australia) as 30 grams in 100 ml.~30 gram load over 2 hours (T = 0 - 2 hours)~60 gram infusion over 6 hours (T = 2-8 hours) which will be repeated at 14, 26 and 38 hours
No Intervention: Usual care
Usual care for septic shock. No vitamin C will be given
Sponsors
Collaborators: University of Melbourne, Monash Medical Centre, The Florey Institute of Neuroscience and Mental Health
Leads: Melbourne Health

This content was sourced from clinicaltrials.gov

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