RecruitingPhase 2ACTRN12617001392358

Vasopressor dependent shock: Intravenous vitamin C versus placebo on vasopressor use. The VALENCIA study

A double-blinded pilot randomized control trial comparing the effect of intravenous vitamin C versus placebo on vasopressor requirements in a cohort of vasopressor dependent patients suffering from a systemic inflammatory response syndrome.

Sponsor

Sir Charles Gairdner Hospital

Enrollment

70 participants

Start Date

Jul 27, 2018

Study Type

Interventional

Conditions

Septic Shock Distributive shock

Summary

Vitamin C is an essential cofactor for multiple metabolic processes. Vitamin C levels are known to fall dramatically following the onset of acute inflammation from any cause. The resulting low levels of vitamin C are associated with worsening sickness and organ failure. Small studies suggest that replacing these levels may of benefit to critically ill patients.. This study is designed to study whether or not replacing Vitamin C will be of any benefit to very sick patients on life support in the intensive care unit. The study hypothesis is that replacement of vitamin C intravenously will result in an improvement in patient outcomes.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria2

Patients requiring significant vasopressor support due to any cause of systemic inflammatory response (Sepsis, OHCA, Acute Pancreatitis, Trauma, etc)
Significant vasopressor requirement is defined as 10 ml/hr (600 mcg/hr) noradrenaline and/or adrenaline (total catecholamine dose to be equal or greater than 600 mcg/hr) after hypovolaemia is clinically excluded as a contributor by lead physician.

Exclusion Criteria7

Vasopressor support required for haemodynamic augmentation to supranormal targets
Neuro-axial anaesthesia (spinal or epidural)
Documented history of Glucose-6-Phosphodiesterase Deficiency (G-6PD) deficiency
Prior enrolment in Vitamin C study
Receiving vitamin C supplementation for another reason (i.e. burns patients)
Expected survival <12 hours
Confirmed or suspected pregnancy

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Interventions

1.5 g intravenous Sodium Ascorbate every 6 hours for 5 days. A review of medication charts by study investigators and sampling of Vitamin C levels levels in 5 randomly selected patients in each arm o

1.5 g intravenous Sodium Ascorbate every 6 hours for 5 days. A review of medication charts by study investigators and sampling of Vitamin C levels levels in 5 randomly selected patients in each arm on day 3 of the study will occur to verify group separation and adherence to protocol.