Not Yet RecruitingPhase 2ACTRN12625001401448

MEGA-dose aSCORbatE for Sepsis 2.0 (MEGASCORES 2.0) – a phase Ib multi-centre open-label randomised controlled trial to determine the feasibility and effectiveness of mega-dose sodium ascorbate in adults with septic shock

Sponsor

The Florey Institute

Enrollment

50 participants

Start Date

Dec 15, 2025

Study Type

Interventional

Conditions

Sepsis

Summary

Our group has recently undertaken studies of mega-dose intravenous sodium ascorbate in septic sheep (up to 3.75 g/kg) and demonstrated a dramatic reversal of organ dysfunction. We have recently completed a pilot study administering sodium ascorbate to critically ill patients with sepsis at a single dose of 60 grams over 6 hours. Sodium ascorbate was well tolerated, increased urine output, and decreased the requirement for medication to support the blood pressure (vasopressors). The study will determine whether mega-dose sodium ascorbate at a dose of 180 grams can decrease the time to weaning from blood pressure support for patients with sepsis and whether it improves other markers of organ dysfunction. If there is a signal for benefit, this trial will establish feasibility for a subsequent larger definitive study.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Inclusion Criteria2

Age 18 – 80 years
Diagnosis of septic shock: Suspected or proven infection AND an arterial lactate >2 mmol/L at any time in the preceding 24 hours AND need for vasopressor therapy at a noradrenaline equivalent dose greater than or equal to 5 µg/min to keep mean arterial pressure greater than or equal to 65 mmHg despite fluid resuscitation therapy at the time of randomisation.

Exclusion Criteria21

Age 80 years
Pregnancy confirmed on either urine or blood sample
Creatinine > 150 mmol/L
Type 1 diabetes mellitus
History of ketoacidosis
Congestive heart failure
Use of SGLT2 Inhibitors
Renal replacement therapy
DNI (do not intubate) orders
Patients with a known history of glucose-6 phosphate dehydrogenase (G-6PD) deficiency
G6PD positivity on BinaxNOWTM G6PD Point-of-Care Qualtitative Rapid Diagnostic Test (Lake Forest, Illinois, USA)
Patients with a history of renal stones or oxaluria
Patients with known or suspected scurvy
Patients previously enrolled in this study
Plasma sodium > 140 mmol/L
Plasma sodium < 125 mmol/L
Haemoglobin < 80 g/L
People for whom preservation of red blood cells is of high clinical priority, e.g Jehova’s Witnesses
Receiving isoprenaline
Anticipated to require intravenous sodium bicarbonate during the intervention period
Persons who have shown hypersensitivity to any of the components of sodium ascorbate

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Interventions

9% sodium ascorbate will be presented in 5% dextrose and administered intravenously through a dedicated lumen of a central or peripheral line as a 45 gram loading dose over one hour (500 mL) followed

9% sodium ascorbate will be presented in 5% dextrose and administered intravenously through a dedicated lumen of a central or peripheral line as a 45 gram loading dose over one hour (500 mL) followed by a continuous infusion of 135 grams over 17 hours (88 ml/hr). This will be prepared by a clinical trials or registered nurse and prescribed by the treating medical team. A plasma or blood sodium level > 150 mmol/L at any time during the intervention period will trigger an immediate reduction in the infusion rate by 1/3 from 88 mL/hr to 59 mL/hr. The infusion rate will be reduced once only and remain at the reduced level until the full dose is administered or until the sodium reaches permanent stopping criteria (> 155 mmol/L).