CompletedPhase 2ACTRN12620000651987

Evaluation of mega-dose Vitamin C for patients with severe infections who are admitted to the intensive care unit

Mega-dose Vitamin C for patients with septic shock: a pilot randomised controlled trial

Sponsor

Professor Rinaldo Bellomo

Enrollment

30 participants

Start Date

Oct 28, 2020

Study Type

Interventional

Conditions

severe infection

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria3

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 Criteria20

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

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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.