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

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

Plain Language Summary

Simplified for easier understanding

This study (the VALENCIA study) tests whether giving high doses of intravenous (IV) vitamin C can reduce the amount of vasopressor drugs (medications that raise dangerously low blood pressure) needed in critically ill patients in the intensive care unit (ICU). When people are severely ill from infections, cardiac arrest, pancreatitis, or trauma, blood pressure can drop to life-threatening levels. Research shows vitamin C levels fall dramatically during these illnesses, and vitamin C plays key roles in protecting organs. This study tests whether replacing it can help patients recover and need less blood pressure support. You may be eligible if: - You are in the ICU and require high-dose vasopressor drugs (noradrenaline and/or adrenaline at 600 mcg/hr or more) - The need for vasopressors is due to a systemic inflammatory condition (such as sepsis, cardiac arrest, pancreatitis, or trauma) - Your doctor has confirmed you are not simply volume-depleted (dehydrated) You may NOT be eligible if: - You are receiving vasopressors to raise blood pressure to artificially high targets - You have had spinal or epidural anaesthesia - You have a known G-6PD enzyme deficiency - You are already enrolled in another vitamin C study or are receiving vitamin C supplements for another reason - Your expected survival is less than 12 hours - You are pregnant Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(2)

Sir Charles Gairdner Hospital - Nedlands

WA, Australia

Royal Perth Hospital - Perth

WA, Australia

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