Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000384550p
Ethics application status
Submitted, not yet approved
Date submitted
8/03/2024
Date registered
3/04/2024
Date last updated
3/04/2024
Date data sharing statement initially provided
3/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot single-centre double-blind randomised controlled trial of the effect of centhaquine on stroke volume in the treatment of vasodilatory hypotension in adults admitted to the intensive care unit
Scientific title
A pilot single-centre double-blind randomised controlled trial of centhaquine in the treatment of vasodilatory hypotension in adults admitted to the intensive care unit
Secondary ID [1] 311648 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hypotension 333155 0
Condition category
Condition code
Cardiovascular 329853 329853 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Centhaquine is to be administered at a dose of 0.01 mg/kg body weight as an Intravenous infusion over 1 hour in 100 ml 0.9% sodium chloride (NaCl) with adherence to the intervention performed via electronic medical record review.
Intervention code [1] 328156 0
Treatment: Drugs
Comparator / control treatment
An intravenous infusion over 1 hour in 100 ml 0.9% sodium chloride (NaCl).
Control group
Placebo

Outcomes
Primary outcome [1] 337624 0
Stroke volume
Timepoint [1] 337624 0
Recorded every hour over the six hours after initiation of the study infusion as recorded in the patient's medical record
Secondary outcome [1] 432574 0
Central venous pressure
Timepoint [1] 432574 0
Recorded every hour over the six hours after initiation of the study infusion as recorded in the patient's medical record
Secondary outcome [2] 432575 0
Mean arterial blood pressure
Timepoint [2] 432575 0
Recorded every hour over the six hours after initiation of the study infusion as recorded in the patient's medical record
Secondary outcome [3] 432576 0
Total dose equivalents of administered vasopressor agents
Timepoint [3] 432576 0
Recorded every hour over the six hours after initiation of the study infusion as recorded in the patient's medical record
Secondary outcome [4] 432577 0
Length of stay in the intensive care unit
Timepoint [4] 432577 0
Upon discharge from the ICU or death, whichever occurs first
Secondary outcome [5] 432578 0
Length of stay in hospital
Timepoint [5] 432578 0
Upon discharge from the hospital or death, whichever occurs first
Secondary outcome [6] 432579 0
Mortality
Timepoint [6] 432579 0
Upon discharge from the hospital or death, whichever occurs first

Eligibility
Key inclusion criteria
Adults aged equal to or greater than 18 years
Vasopressor dependent hypotension (vasopressor therapy to maintain a mean arterial pressure greater than 65 mmHg)
Cardiac index > 2.3 litres per minute per meters squared or central venous oxygen saturation > 70 percent
Central venous access and an arterial line present
Expected to require vasopressor support for at least 24 hours
Informed consent provided by the patient or medical treatment decision maker
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cardiac surgery patients
Suspected cardiogenic shock
Greater than 24 hours continuous vasoactive therapy prior to enrolment
Chronic haemodialysis or peritoneal dialysis
Expected survival less than 24 hours
Suspected or confirmed pregnancy
Previously enrolled into the this trial

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)
central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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
Statistical analysis will be performed using computerised software (Stata MP/16.0, StataCorp, College Station, Texas, USA). Baseline characteristics will be reported as frequencies and percentages, means with standard deviation, or medians and interquartile ranges. Summary statistics to compare baseline characteristics will include t-test, chi square test, and Wilcoxon rank sum test, as dictated by data type. The primary outcome will be reported using multivariable mixed effects linear regression models. Secondary outcomes will be explored using multivariable linear regression models for continuous outcomes and logistic regression models for binary outcomes. No imputation will be performed for missing data. A two-sided p-value <0.05 will be considered significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26244 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 42212 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 315976 0
Hospital
Name [1] 315976 0
Austin Hospital
Country [1] 315976 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Country
Australia
Secondary sponsor category [1] 318117 0
Individual
Name [1] 318117 0
Dr Heidi Gaulke
Address [1] 318117 0
Country [1] 318117 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314797 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 314797 0
https://www.austin.org.au/Office-for-Research/
Ethics committee country [1] 314797 0
Australia
Date submitted for ethics approval [1] 314797 0
22/03/2024
Approval date [1] 314797 0
Ethics approval number [1] 314797 0

Summary
Brief summary
Current pharmacotherapy options of haemodynamic support in critically ill patients with vasodilatory hypotension are limited. Centhaquine is a novel agent that has a dual action on the sympathetic system and may helped in the management of hypotensive states. We hypothesise that, compared to placebo, centhaquine will be associated with higher stroke volume, higher central venous pressure, higher mean arterial pressure, and lower vasopressor agent use over six hours after initiation of the study infusion. We plan to enrol 18 adult patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132766 0
Prof Rinaldo Bellomo
Address 132766 0
Austin Hospital, 145 Studley Road, Heidelberg, Victoria 3084
Country 132766 0
Australia
Phone 132766 0
+61 394965992
Fax 132766 0
Email 132766 0
rinaldo.bellomo@austin.org.au
Contact person for public queries
Name 132767 0
Rinaldo Bellomo
Address 132767 0
Austin Hospital, 145 Studley Road, Heidelberg, Victoria 3084
Country 132767 0
Australia
Phone 132767 0
+61 394965992
Fax 132767 0
Email 132767 0
rinaldo.bellomo@austin.org.au
Contact person for scientific queries
Name 132768 0
Rinaldo Bellomo
Address 132768 0
Austin Hospital, 145 Studley Road, Heidelberg, Victoria 3084
Country 132768 0
Australia
Phone 132768 0
+61 394965992
Fax 132768 0
Email 132768 0
rinaldo.bellomo@austin.org.au

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


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.