Mega-dose Ascorbate for Sepsis (MEGA-SCORES) in critically ill adults - a pilot feasibility phase 1 double blind randomised controlled trial

Central Adelaide Local Health Network0 个研究点目标入组 30 人开始时间: 2023年11月17日最近更新: 2024年3月4日

适应症

试验速览

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•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

发起方

Central Adelaide Local Health Network