UnknownPhase 1

High-dose Intravenous Vitamin C in Patients With Septic Shock

Australia30 participantsStarted 2021-09-27

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * Age \<18 or \> 80 years * Pregnant * DNI (do not intubate) orders i.e., Goals of Care other than A * Patients with a primary admission diagnosis of a traumatic brain injury * Patients with features of septic shock admitted in the ICU \> 24 hours * Patients with a known history of glucose-6 phosphate dehydrogenase (G-6PD) deficiency * Patients with a history of renal stones * Patients with known or suspected scurvy * Patients previously enrolled in this study * Plasma sodium \>150 mmol/L * Plasma sodium \< 130 mmol/L * Haemoglobin \< 90 g/L * Jehova's witness * Receiving isoprenaline

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time to cessation of vasopressor support

Timeframe: 7 days

Trial details

NCT IDNCT04796636

SponsorMelbourne Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-22

Contact for this trial

Mark P Plummer, PhD

+61 419708399 mark.plummer@mh.org.au

View on ClinicalTrials.gov More Sepsis, Severe trials