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Trial registered on ANZCTR


Registration number
ACTRN12617001392358
Ethics application status
Approved
Date submitted
27/09/2017
Date registered
29/09/2017
Date last updated
27/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Vasopressor dependent shock: Intravenous vitamin C versus placebo on vasopressor use. The VALENCIA study
Scientific title
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.
Secondary ID [1] 292992 0
Nil known
Universal Trial Number (UTN)
U1111-1202-8405
Trial acronym
VALENCIA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Distributive shock 304900 0
Systemic inflammatory response syndrome 304901 0
Septic Shock 304902 0
Condition category
Condition code
Inflammatory and Immune System 304223 304223 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 299232 0
Treatment: Drugs
Comparator / control treatment
100 ml 0.9% Sodium Chloride intravenous infusion every 6 hours for 5 days.
Control group
Placebo

Outcomes
Primary outcome [1] 303518 0
Duration of vasopressor usage (hrs) post commencement of study intervention
Timepoint [1] 303518 0
Hourly post commencement of study intervention for 5 days.
Primary outcome [2] 303519 0
Total dose of vasopressor usage (mg)
Timepoint [2] 303519 0
5 days post commencement of study intervention
Secondary outcome [1] 339160 0
Intensive Care or High Dependency Unit length of stay
Timepoint [1] 339160 0
Hours and days post commencement of study intervention
Secondary outcome [2] 339161 0
Duration of mechanical ventilation
Timepoint [2] 339161 0
Hourly post commencement of study intervention for 5 days.
Secondary outcome [3] 339162 0
Mortality
Timepoint [3] 339162 0
At 28 days post commencement of study intervention

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Assuming mean duration of vasopressor for control group is 72 hours and the treatment group is 48 hours (absolute reduction of 24 hours, s.d 36 hours for control group and 24 hours for treatment group) and using the Mann-Whitney non-parametric method to estimate the sample size: 28 per group.

To allow for lost to follow-up, sample size increased by 20% - total sample size of 70 patients.

Statistical analysis plan to be finalised prior to unblinding of any data

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 9118 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [2] 9119 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 17621 0
6009 - Nedlands
Recruitment postcode(s) [2] 17622 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 297618 0
Hospital
Name [1] 297618 0
Sir Charles Gairdner Hospital
Address [1] 297618 0
Sir Charles Gairdner Hospital
Intensive Care Department
Hospital Avenue, Nedlands,
Perth 6009, Western Australia
Country [1] 297618 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Sir Charles Gairdner Hospital
Intensive Care Department
Hospital Avenue, Nedlands,
Perth 6009, Western Australia
Country
Australia
Secondary sponsor category [1] 296635 0
None
Name [1] 296635 0
Address [1] 296635 0
Country [1] 296635 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298708 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
Ethics committee address [1] 298708 0
Sir Charles Gairdner Hospital
Level 2, A Block
Hospital Avenue
NEDLANDS WA 6009
Ethics committee country [1] 298708 0
Australia
Date submitted for ethics approval [1] 298708 0
15/11/2017
Approval date [1] 298708 0
19/04/2018
Ethics approval number [1] 298708 0
RGS0000000607

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77970 0
Dr Matthew Anstey
Address 77970 0
Sir Charles Gairdner Hospital
Intensive Care Unit
Level 4, G Block
Hospital Avenue
NEDLANDS WA 6009
Country 77970 0
Australia
Phone 77970 0
+61 8 6457 3333
Fax 77970 0
Email 77970 0
matthew.anstey@health.wa.gov.au
Contact person for public queries
Name 77971 0
Dr Matthew Anstey
Address 77971 0
Sir Charles Gairdner Hospital
Intensive Care Unit
Level 4, G Block
Hospital Avenue
NEDLANDS WA 6009
Country 77971 0
Australia
Phone 77971 0
+61 8 6457 3333
Fax 77971 0
Email 77971 0
matthew.anstey@health.wa.gov.au
Contact person for scientific queries
Name 77972 0
Dr Matthew Anstey
Address 77972 0
Sir Charles Gairdner Hospital
Intensive Care Unit
Level 4, G Block
Hospital Avenue
NEDLANDS WA 6009
Country 77972 0
Australia
Phone 77972 0
+61 8 6457 3333
Fax 77972 0
Email 77972 0
matthew.anstey@health.wa.gov.au

No information has been provided regarding IPD availability
Summary results
No Results