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 range18 Years – 80 Years

SexALL

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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

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