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.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617001392358

Acronym

VALENCIA

Enrollment

Registered

2017-09-29

Start date

2018-07-27

Completion date

2019-08-06

Last updated

2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 on day 3 of the study will occur to verify group separation and adherence to protocol.

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

Inclusion criteria

1) Patients requiring significant vasopressor support due to any cause of systemic inflammatory response (Sepsis, OHCA, Acute Pancreatitis, Trauma, etc) 2) 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 criteria

1) Vasopressor support required for haemodynamic augmentation to supranormal targets 2) Neuro-axial anaesthesia (spinal or epidural) 3) Documented history of Glucose-6-Phosphodiesterase Deficiency (G-6PD) deficiency 4) Prior enrolment in Vitamin C study 5) Receiving vitamin C supplementation for another reason (i.e. burns patients) 6) Expected survival <12 hours 7) Confirmed or suspected pregnancy

Outcome results