Mega-dose Ascorbate for Sepsis (MEGA-SCORES) - a pilot phase 1 double blind randomised controlled trial
- Conditions
- Septic shockInfection - Other infectious diseases
- Registration Number
- ACTRN12623001191684
- Lead Sponsor
- Central Adelaide Local Health Network
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 30
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method