None listed
Conditions
Brief summary
Septic shock, which is a state of severe infection, triggers a complex response by the body (the inflammatory response) that causes a decrease in blood pressure and subsequently one or more organ systems to fail when blood supply to these organs is reduced. When patients are admitted to intensive care with sepsis and/or septic shock they receive a range of therapies including antibiotics, intravenous fluids and strong drugs to improve blood pressure, known as vasopressor drugs.. However, these therapies have significant side effects and it would be desirable to restore a safe blood pressure quickly. Over the last few years, evidence has emerged that high dose Vitamin C administered via infusion may help to restore blood pressure with almost no side effects. This makes treatment with Vitamin C potentially desirable in patients with on-going low-blood pressure due to septic shock. However, this effect might be dose dependent and we do not know the effect of mega dose Vitamin C. In response, we will perform a clinical research project, known as a randomised controlled trial, to evaluate whether giving intravenous mega-dose Vitamin C (total of 60 grams) compared to placebo, improves physiological outcomes in a population of 30 patients admitted to intensive care with a diagnosis of suspected or confirmed sepsis.
Interventions
Vitamin C 30 grams [100 ml] diluted with 150 ml of 5% Dextrose infused intravenously over 1 hour followed immediately by Vitamin C 30 grams [100 ml] diluted with 150 ml of 5% Dextrose infused intravenously over 5 hours with monitoring of the fluid administered occurring via audit of the ICU fluid balance chart.
Sponsors
Professor Rinaldo Bellomo
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 No maximum
Healthy volunteers
No
Inclusion criteria
Suspected or confirmed septic shock defined as an acute increase of: - equal to or greater than 2 sequential organ failure assessment (SOFA) points - need for continuous intravenous vassopressor therapy to maintain a mean arterial blood pressure of greater than 65 mmHg for greater than 2 hours and a serum lactate of greater than 2 mmol/L (despite adequate fluid resuscitation) within the previous 24 hours.
Exclusion criteria
Aged less than 18 years Suspected or confirmed pregnancy Do not resuscitate or do not intubate order Death is deemed to be imminent or inevitable during this index hospital admission Patients with know human immunodeficiency virus (HIV) infection Patients with known glucose-6 phosphate dehydrogenanse (G-6PD) deficiency Patients transferred from another intensive care unit or hospital with a diagnosis of septic shock for greater than 24 hours Patient with known chronic iron overload due to iron storage and other diseases Patient previously enrolled in this study Patients with chronic haemodialysis or peritoneal dialysis. Patients require renal replacement therapy within next 24 hours. Patients baseline blood sodium level is equal to or greater than 155 mEq/L Patients creatinine at enrolment is equal to or greater than 150 mmol/L Patients with known or suspected: - history of oxalate nephropathy or hyperoxaluria - short blow syndrome or severe fat malabsorption - acute beri-beri disease - acute Wernicke's encephalopathy - malaria - scurvy
Outcome results
None listed