Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000721808
Ethics application status
Approved
Date submitted
10/03/2021
Date registered
9/06/2021
Date last updated
30/06/2023
Date data sharing statement initially provided
9/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Vasopressor Infusion via Peripheral vs Central Access in patients with shock.
Scientific title
Effect of Vasopressor Infusion via Peripheral vs Central Access on 60 day survival in patients with shock - (The VIPCA trial)
Secondary ID [1] 303624 0
none
Universal Trial Number (UTN)
Trial acronym
The VIPCA Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
shock 321026 0
Condition category
Condition code
Cardiovascular 318829 318829 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Common treatment applied to both groups
The VPI will be initiated via the PIVC in both groups at a time chosen by the treating clinician as per standard practice (it is standard practice for all patients with shock to have at least one PIVC inserted as soon as possible in Australian Emergency Departments)
All other treatments for the underlying condition that has necessitated VPI (such as antibiotics, source control procedures, fluid therapy) will be at the discretion of the treating clinician

Peripheral Vasopressor group (Late Central group) – usual care (as defined below) plus:
Peripheral Intravenous Canula (PIVC), 18-gauge preferred
Delayed insertion of central venous line (CVC) – A CVC is not to be inserted for at least 12 hours from randomisation.
A CVC can be inserted earlier than 12 hours if required for the following reasons:
Noradrenaline-equivalent dose greater than or equal to 0.2mcg/kg/min
Need for irritant medications/infusions that cannot be administered via a PIVC
Failure of drug delivery via PIVC
Complications of PIVC including extravasation of Vasopressor Infusion (VPI), or tissue necrosis

The PIVC/CVC will be inserted by ED or ICU doctors and monitored by ED and ICU nurses
The insertion of the PIVC is anticipated to take 5 minutes, delayed insertion of the CVC is anticipated to take approximately 20 minutes

Early Central VPI group - usual care plus
Patients in the Early Central group will have a CVC inserted within 4 hours of randomisation

Usual care includes: a combination of cardiopulmonary resuscitation, fluid resuscitation, vasopressors given as bolus &/or infusion, source control including surgical intervention, antibiotics as well as investigations etc. and in accordance with standard medical practice.
A VPI includes any of the following medications – Noradrenaline, Adrenaline, Metaraminol, Phenylephrine and Vasopressin.
Intervention code [1] 319930 0
Treatment: Devices
Comparator / control treatment
Early central vasopressor group (Early Central group) – usual care plus:
Early insertion of central line for administering a VPI – central line to be inserted as soon as practical, after randomisation (target time to central delivery of VP infusion is 4 hours from randomisation)
Central line insertion will be done under full aseptic precautions, utilising ultrasound for insertion and X-Ray for confirmation
Usual care for this group will be the same as Late Central Group
CVC will be inserted by ED and ICU doctors depending on the location of the patient
baseline vasopressor dose .0.2mcg/kg/min Noradrenaline equivalent via CVC
Control group
Active

Outcomes
Primary outcome [1] 326776 0
Primary feasibility outcome will be a composite of the following:
Protocol adherence (time to central line insertion in both groups; adherence to all aspects of trial protocol) as determined from audit of hospital medical records
Randomisation rate (target rate is 4 patients per month) determined by review of recruitment log
Randomisation:Eligibility ratio (target 0.80) determined by review of recruitment log
Timepoint [1] 326776 0
Monthly from the date of recruitment of first patient
Primary outcome [2] 327638 0
Days alive and out of hospital up to day 60 (DAH60)
Timepoint [2] 327638 0
Day 60 after randomisation
Secondary outcome [1] 392645 0
Complications related to CVC and PIVC (local, regional or systemic) as determined by review of patient medical records
Timepoint [1] 392645 0
daily until discharge from ICU
Secondary outcome [2] 394084 0
Number of peripheral venous punctures and PIVC’s by review of patient medical records
Timepoint [2] 394084 0
daily until off vasopressor infusion
Secondary outcome [3] 394085 0
Line-associate bloodstream infection by review of patient medical records
Timepoint [3] 394085 0
daily until discharge from ICU
Secondary outcome [4] 394086 0
Number of central lines inserted by review of patient medical records
Timepoint [4] 394086 0
Daily Until discharge from ICU
Secondary outcome [5] 396034 0
Missing data will be assessed by an audit of the entire study database by the trial statistician
Timepoint [5] 396034 0
Assessed once after the conclusion of day 60 assessment for the last enrolled patient.

Eligibility
Key inclusion criteria
* Patients admitted to Caboolture Hospital ED
* Any unplanned admission to Caboolture Hospital ICU
* greater than 18 years
* Treating clinician has deemed that a Vasopressor Infusion is required
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnancy or suspected pregnancy
* Treating clinician believes that survival beyond 48 hours is unlikely or patient being admitted to ICU solely for Palliation or Organ Donation
* Has received vasopressor infusion for 4 hours
* Requiring >0.1mcg/kg/min noradrenaline (or equivalent dose of other vasopressors) at the time of screening; or requiring >1 vasopressor agent
* Patient already has a CVC in-situ or requires a CVC insertion for specific therapies other than vasopressors (e.g., total parenteral nutrition, severe electrolyte derangements like: K+ less than or equal to 2.0 mmol/L, PO4-2 less than or equal to 0.3 mmol/L, or for Ca+2 infusion for CRRT)

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)
using sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization with allocation concealment will be performed using a pre-generated randomization sequence and sealed, opaque envelopes. Randomization will be stratified by location of randomization i.e., ED or ICU. Simple randomization using a randomization table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2022
Actual
1/03/2023
Date of last participant enrolment
Anticipated
30/11/2023
Actual
Date of last data collection
Anticipated
1/12/2023
Actual
Sample size
Target
40
Accrual to date
18
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 18884 0
Caboolture Hospital - Caboolture
Recruitment postcode(s) [1] 33382 0
4510 - Caboolture

Funding & Sponsors
Funding source category [1] 308686 0
Hospital
Name [1] 308686 0
Caboolture Hospital
Country [1] 308686 0
Australia
Primary sponsor type
Hospital
Name
Caboolture Hospital
Address
120 McKean Street
Caboolture QLD 4510
Country
Australia
Secondary sponsor category [1] 309567 0
None
Name [1] 309567 0
Address [1] 309567 0
Country [1] 309567 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308038 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 308038 0
Ethics committee country [1] 308038 0
Australia
Date submitted for ethics approval [1] 308038 0
30/03/2021
Approval date [1] 308038 0
27/08/2021
Ethics approval number [1] 308038 0
74377

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109302 0
Dr Yogesh Vilas Apte
Address 109302 0
Intensive Care Unit
Caboolture Hospital
120 McKean Street
Caboolture QLD 4510
Country 109302 0
Australia
Phone 109302 0
+61 433 479 623
Fax 109302 0
Email 109302 0
[email protected]
Contact person for public queries
Name 109303 0
Yogesh Vilas Apte
Address 109303 0
Intensive Care Unit
Caboolture Hospital
120 McKean Street
Caboolture QLD 4510
Country 109303 0
Australia
Phone 109303 0
+61 433 479 623
Fax 109303 0
Email 109303 0
[email protected]
Contact person for scientific queries
Name 109304 0
Yogesh Vilas Apte
Address 109304 0
Intensive Care Unit
Caboolture Hospital
120 McKean Street
Caboolture QLD 4510
Country 109304 0
Australia
Phone 109304 0
+61 433 479 623
Fax 109304 0
Email 109304 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data can be made available for sharing. All individual participant data in the trial database can be made available for sharing after deidentification and requisite approval.s
When will data be available (start and end dates)?
August 2021 to January 2023
Available to whom?
Applications from investigators with suitable academic capability to conduct the proposed work will be given consideration.
Available for what types of analyses?
All relevant analyses
How or where can data be obtained?
Any proposal will require approval from the The Prince Charles Hospital Human Research Ethics Committee ([email protected]) prior to sharing of any patient data. If a proposal is approved, a signed data transfer agreement will be required before data sharing. The proposal, approval and transfer agreement can be sent to [email protected] for access to the data.


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
No additional documents have been identified.