None listed
Conditions
Brief summary
Sepsis is a major health problem worldwide and in New Zealand. Despite a massive effort in recent years to develop therapies, none has as yet proven successful in reducing mortality in patients with sepsis, which currently remains the leading cause of death in most intensive care units. Studies indicate that critically ill patients, including those with sepsis, exhibit very low vitamin C levels compared to healthy people. Furthermore, recent preclinical trials and clinical studies indicate a potential role for vitamin C in decreasing inflammation, vasopressor requirements, and multiple organ failure, and improving outcomes in patients with severe sepsis and septic shock, including decreased mortality. Our study will be a double blind randomised placebo controlled trial to test the efficacy of intravenous (IV) vitamin C administration in patients with severe sepsis, with a specific focus on vasopressor requirements. Participants with severe sepsis will be recruited after being admitted to the Christchurch Hospital Intensive Care Unit (ICU). Forty participants will be randomised into two groups: IV vitamin C (100 mg/kg body weight/day) or IV placebo (1:1 ratio) for a duration of 4 days. Blood and urine samples will be collected daily from patients to measure vitamin C levels along with selected biomarkers of inflammation and organ function. The analyses of these biomarkers, which relate to the severity of sepsis, will determine whether levels are changed in patients who receive the intervention. Clinical outcomes will also be monitored; we hypothesise that the patients who receive vitamin C will have improved outcomes.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
1. Receiving IV antimicrobial therapy specifically for infection 2. Receiving >/=5 µg/min (>/=0.06 µg/kg/min) noradrenaline/adrenaline 3. Evidence of organ dysfunction - SOFA >/= 2 for at least ONE of: respiratory system (PaO2/FiO2 < 300) liver (bilirubin >33) coagulation (platelets <100) renal system (creatinine >171)
Exclusion criteria
1. Age < 18 years 2. Consent cannot be obtained 3. Patient not expected to survive 24 hours 4. Known glucose-6-phosphate dehydrogenase (G6PD) deficiency 5. Known or suspected pregnancy or breastfeeding