Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000793314
Ethics application status
Approved
Date submitted
25/05/2017
Date registered
30/05/2017
Date last updated
20/12/2018
Date data sharing statement initially provided
20/12/2018
Date results information initially provided
20/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The Vitamin C after Cardiac Surgery Study
Scientific title
A Pilot, Randomised, Double-Blind Study of Vitamin C in the treatment of Vasoplegic Shock after Cardiac Surgery
Secondary ID [1] 292044 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The VICCSS study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low blood pressure 303443 0
Vasoplegia 303466 0
Condition category
Condition code
Cardiovascular 302851 302851 0 0
Other cardiovascular diseases
Surgery 302873 302873 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravenous Vitamin C 1500 mg administered 6-hourly given every six hours until no vasopressor is required for a period of 24 hours or a maximum of 96 hours (4 days) or the patient is discharged from ICU, whichever occurs first) with clinical monitoring and evaluation of the patient's blood pressure prior to study drug administration
Intervention code [1] 298170 0
Treatment: Drugs
Comparator / control treatment
Intravenous normal saline 0.9% administered 6-hourly given every six hours until no vasopressor is required for a period of 24 hours or a maximum of 96 hours (4 days) or the patient is discharged from ICU, whichever occurs first).with clinical monitoring and evaluation of the patient's blood pressure prior to study drug administration
Control group
Placebo

Outcomes
Primary outcome [1] 302246 0
Cessation of vasopressor therapy
Timepoint [1] 302246 0
Cessation of vasopressor therapy is defined as the time from randomisation to cessation of vasopressor therapy (defined as four consecutive hours of vasopressor-free time).
Secondary outcome [1] 335267 0
Total dose of noradrenaline given in the first 48-hours following randomisation
Timepoint [1] 335267 0
Accumulative dose in milligrams of noradrenaline administered from randomisation until 48-hours post randomisation as documented in the patient's medical record
Secondary outcome [2] 335268 0
Duration of intensive care unit admission
Timepoint [2] 335268 0
Duration in hours from randomisation until discharge from the intensive care unit as documented in the patient's medical record
Secondary outcome [3] 335269 0
Mortality at ICU discharge
Timepoint [3] 335269 0
Mortality status at the time of intensive care unit dischage as documented in the patient's medical record
Secondary outcome [4] 335270 0
Mortality at hospital discharge
Timepoint [4] 335270 0
Mortality status at the time of hospital dischage as documented in the patient's medical record

Eligibility
Key inclusion criteria
Patients aged greater than or equal to 18 years
Admitted to the ICU for less than 6 hours following cardiac surgery
Vasoplegic syndrome in the postoperative period defined as:
a) need for continuous vasopressor infusion to maintain a mean arterial pressure greater than 65 mmHg AND
b) cardiac index equal to or greater than 2.2 L/min/m2 OR central venous O2 saturation less than 60%
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
Use of vasopressors or inotropes in the preoperative period
Off-pump cardiac surgery
Chronic use of corticosteroid therapy
History of oxalate nephrolithiasis
Haemochromatosis
Glucose 6 phosphate dehydrogenase deficiency
Treating physician believes there is a cause for shock other than vasoplegic syndrome (eg: bleeding, fluid requirement, pneumothorax, pacemaker issues, or heart failure)
Treating clinician believes the study is not in the patient’s best interests

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)
Blinded allocation using sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted block randomisation
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
Safety/efficacy
Statistical methods / analysis
Outcomes will be compared after log transformation where appropriate. Comparisons will be made using t-test and ANOVA for repeated-measures or Wilcoxon rank-signed test and Kruskall-Wallis according to the underlying distribution for continuous data and Chi-square for categorical data. Logistic regression analysis will also be performed to adjust for baseline imbalances. Analysis will be on an intention-to-treat basis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/06/2017
Actual
9/11/2017
Date of last participant enrolment
Anticipated
Actual
24/10/2018
Date of last data collection
Anticipated
Actual
19/12/2018
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 8149 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 16210 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 9491 0
New Zealand
State/province [1] 9491 0
Wellington

Funding & Sponsors
Funding source category [1] 296575 0
Hospital
Name [1] 296575 0
Austin Hospital
Country [1] 296575 0
Australia
Primary sponsor type
Hospital
Name
Austin Hospital
Address
145 Studley Road
Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 295532 0
Individual
Name [1] 295532 0
Professor Rinaldo Bellomo
Address [1] 295532 0
Director, Intensive Care Research
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Country [1] 295532 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297792 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 297792 0
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Ethics committee country [1] 297792 0
Australia
Date submitted for ethics approval [1] 297792 0
03/04/2017
Approval date [1] 297792 0
17/05/2017
Ethics approval number [1] 297792 0
HREC/17/Austin/162

Summary
Brief summary
Patients after cardiac surgery often develop a low blood pressure because of the inflammation associated with surgery and bypass. This low blood pressure is mostly due to the small blood vessels losing their normal tightness. This condition is called “vasoplegia”. When vasoplegia occurs after cardiac surgery, it can lower the blood pressure to dangerous levels, which can lead to organ malfunction and may even be life-threatening. In order to maintain safety under such a situation, intensive care doctors administer drugs that tighten blood vessels. These drugs are called vasopressors. Such vasopressors can restore safe levels of blood pressure. However, they have significant side effects. Thus, it would be desirable to restore a safe blood pressure without the use of such vasopressor drugs. Over the last few years, evidence has emerged that high dose vitamin C injected into the blood stream can restore the normal tightness of blood vessels and is free of side effects. This makes treatment with vitamin C potentially desirable in cardiac surgery patients with vasoplegia. However, no studies have assessed whether vitamin C at high dose is effective in this setting. Thus, we propose to conduct a pilot study to test whether vitamin C at high dose can improve blood pressure and decrease the need for vasopressor drugs in patients with vasoplegia after cardiac surgery.
Trial website
Not applicable
Trial related presentations / publications
Nil
Public notes
Attachments [1] 1733 1733 0 0
/AnzctrAttachments/373018-20170517 HREC17Austin162 May17 (FULL ETHICS APPROVAL).pdf (Ethics approval)
Attachments [2] 2376 2376 0 0
/AnzctrAttachments/373018-20171206 HREC17Austin162 Dec17 (Ethics PA and PICF's).pdf (Ethics approval)

Contacts
Principal investigator
Name 75130 0
Prof Rinaldo Bellomo
Address 75130 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Country 75130 0
Australia
Phone 75130 0
+61394965992
Fax 75130 0
+61394963932
Email 75130 0
rinaldo.bellomo@austin.org.au
Contact person for public queries
Name 75131 0
A/Prof Glenn Eastwood
Address 75131 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Country 75131 0
Australia
Phone 75131 0
+61394964835
Fax 75131 0
+61394963932
Email 75131 0
glenn.eastwood@austin.org.au
Contact person for scientific queries
Name 75132 0
Prof Rinaldo Bellomo
Address 75132 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Country 75132 0
Australia
Phone 75132 0
+61394965992
Fax 75132 0
+61394963932
Email 75132 0
rinaldo.bellomo@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA Pilot, Double-Blind, Randomized, Controlled Trial of High-Dose Intravenous Vitamin C for Vasoplegia After Cardiac Surgery.2020https://dx.doi.org/10.1053/j.jvca.2019.08.034
Dimensions AIUnderstanding the rationale for parenteral ascorbate (vitamin C) during an acute inflammatory reaction: a biochemical perspective2018https://doi.org/10.1016/s1441-2772(23)00687-7
N.B. These documents automatically identified may not have been verified by the study sponsor.