None listed
Conditions
Brief summary
This is a phase I, feasibility, prospective, multi-centre, double-blinded randomised placebo-controlled trial in ICU patients with septic shock to test whether the intravenous administration of mega-dose sodium ascorbate is safe and feasible, shortens the time to weaning from vasopressor support and leads to an improvement in biomarkers of sepsis compared to placebo. The study hypothesis is that the mega-dose sodium ascorbate in early septic shock will be safe and feasible.
Interventions
Sodium ascorbate is provided by the manufacturer (Orthomolecular Medisearch Laboratory P/L, Braeside, Victoria, Australia) as 30 grams in 100 mL presented in a plain glass vial as a clear, colourless solution. Clinical Trials Pharmacy at each participating site will aseptically prepare the study medication with a diluent to yield a solution in 1000 mL.
Study treatment medication will be administered via a dedicated lumen of a peripheral or central venous catheter as a continuous infusion with a
Sodium ascorbate is provided by the manufacturer (Orthomolecular Medisearch Laboratory P/L, Braeside, Victoria, Australia) as 30 grams in 100 mL presented in a plain glass vial as a clear, colourless solution. Clinical Trials Pharmacy at each participating site will aseptically prepare the study medication with a diluent to yield a solution in 1000 mL. Study treatment medication will be administered via a dedicated lumen of a peripheral or central venous catheter as a continuous infusion with a bolus dose of 0.5 g/kg ideal body weight (IBW) administered over 2 hours followed by 2.5 g/kg (IBW) administered over 22 hours. The maximum ideal body weight for the infusion rate will be 100 kg (maximum total dose 300 grams, maximum total volume 2000 mL over 24 hours). Adherence to intervention will be closely monitored via the electronic medical records.
Sponsors
Central Adelaide Local Health Network
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
INCLUSION CRITERIA - Aged 18-80 years - Diagnosis of septic shock defined as: > Suspected or proven infection; AND > An arterial lactate >2 mmol/L at any time in the preceding 24 hrs; AND > Need for vasopressor therapy at a noradrenaline equivalent dose greater than or equal to 5 µg/min to keep MAP >65 mmHg for >2 hrs despite fluid resuscitation therapy. - Vasopressor running as a continuous infusion for <48 hrs at the time of randomisation
Exclusion criteria
EXCLUSION CRITERIA - Aged <18 or >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 - Patients with a history of renal stones or oxaluria - Patients with known or suspected scurvy - Patients previously enrolled in this study - Plasma sodium <130 or >150 mmol/L - Haemoglobin < 80 g/L - People for whom preservation of red blood cells is of high clinical priority - 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
Outcome results
None listed