Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000950864
Ethics application status
Approved
Date submitted
14/05/2021
Date registered
21/07/2021
Date last updated
15/02/2023
Date data sharing statement initially provided
21/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Urinary sodium to manage patients with acute heart failure
Scientific title
Evaluating the role of urinary sodium in the management of acute heart failure
Secondary ID [1] 304179 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart failure
 321872 0
Condition category
Condition code
Cardiovascular 319598 319598 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Urinary sodium test will be obtained from acute heart failure patients admitted to the hospital at presentation and within the first 6 hours after the commencement of loop diuretic, then 6-hourly, for the first 48 hours. Diuretics dose will be adjusted by a cardiologist based on urinary sodium and will be given by the ward nurse. Urinary sodium samples will be obtained by ward staff. Interventions will be recorded in patients' medical charts.
This adjustment to the timing of taking the first UNa after the administration of IV diuretic was made after recruiting the first 15 patients.
Intervention code [1] 320510 0
Treatment: Other
Comparator / control treatment
In the standard care arm, the treating clinical team (cardiologist) will be left to assess the efficacy of diuresis and regulate the dose of diuretic based on the assessment of the clinical signs of congestion (pulmonary rales, jugular venous pressure, orthopnea and peripheral oedema), daily weight change and net fluid balance.
Control group
Active

Outcomes
Primary outcome [1] 327831 0
Length of hospital stay
Number of days admitted, assessed from patient's chart
Timepoint [1] 327831 0
During index hospital admission for acute heart failure
Secondary outcome [1] 397347 0
All-cause death (efficacy outcome)
Based on patient's chart and follow up contact
Timepoint [1] 397347 0
Up to 30 days post discharge
Secondary outcome [2] 397348 0
Rehospitalisation (efficacy outcome)
Based on patients' chart and follow up contact
Timepoint [2] 397348 0
Up to 30 days post discharge
Secondary outcome [3] 397349 0
Acute kidney injury (safety outcome)
Based on daily blood tests (creatinine>1.5-2 times from baseline or creatinine increased by at least 26.4 micromole/l) or need for dialysis
Timepoint [3] 397349 0
Daily during admission
Secondary outcome [4] 397350 0
Worsening heart failure (safety outcome)
Based on patient evaluation by cardiologist (requiring the use of inotropes or mechanical circulatory support)
Timepoint [4] 397350 0
Daily during admission
Secondary outcome [5] 397351 0
Diuretic adverse events (safety outcome)
Based on blood test and patient evaluation (electrolyte imbalance (k<3.5), arrhythmia secondary to electrolyte imbalance and low blood pressure(<90mmHg) secondary to over diuresis)
Timepoint [5] 397351 0
Daily during admission
Secondary outcome [6] 397352 0
Weight change (other marker of clinical improvement)
Based on daily weight by digital weigh scale, documented in patients' charts
Timepoint [6] 397352 0
Daily during admission
Secondary outcome [7] 397353 0
Congestion (other marker of clinical improvement)
Based on clinical examination of patient by cardiologist, using congestion score (Jugular venous pressure , pulmonary rales, peripheral oedema, orthopnea)
Timepoint [7] 397353 0
During admission( at presentation and at 48 hours/discharge)
Secondary outcome [8] 397354 0
BNP (other marker of clinical improvement)
Based on blood tests
Timepoint [8] 397354 0
At presentation and at 48 hours/discharge
Secondary outcome [9] 397359 0
Symptom improvement, based on patient reported Likert scale questionnaire (5-point scale: marked improvement, ,mild improvement, unchanged, mild worsening, marked worsening)
Timepoint [9] 397359 0
At presentation and at 48 hours/discharge

Eligibility
Key inclusion criteria
at least 18 years old, admitted under cardiology team with the primary diagnosis of
acute heart failure
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Haemodynamically unstable patients, requiring inotropic or mechanical circulatory
support
2. Patients with severe kidney dysfunction, on dialysis, or aneuric patients
3. Unable to provide informed consent

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The analyses will be performed after monitoring and cleaning of data gathered from all
patients. All analyses will be performed using intent-to-treat principles. Analyses will be
performed by the investigators and a statistician, using the latest version of STATA statistics.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/07/2021
Actual
1/10/2021
Date of last participant enrolment
Anticipated
31/12/2021
Actual
31/08/2022
Date of last data collection
Anticipated
31/01/2022
Actual
30/09/2022
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 19885 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 34586 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 308557 0
Hospital
Name [1] 308557 0
Metro North Health, The Prince Charles Hospital (TPCH)
Country [1] 308557 0
Australia
Primary sponsor type
Hospital
Name
Metro North Health, TPCH
Address
627 Rode road, Chermside, QLD, 4032
Country
Australia
Secondary sponsor category [1] 309463 0
None
Name [1] 309463 0
Address [1] 309463 0
Country [1] 309463 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308499 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 308499 0
Ethics committee country [1] 308499 0
Australia
Date submitted for ethics approval [1] 308499 0
01/03/2021
Approval date [1] 308499 0
15/04/2021
Ethics approval number [1] 308499 0
74043

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

Contacts
Principal investigator
Name 110918 0
A/Prof Isuru Ranasinghe
Address 110918 0
The Prince Charles Hospital, Cardiology department.
627 Rode road, Chermside, QLD 4032
Country 110918 0
Australia
Phone 110918 0
+61 7 49206227
Fax 110918 0
Email 110918 0
[email protected]
Contact person for public queries
Name 110919 0
Maryam Khorramshahi Bayat
Address 110919 0
The Prince Charles Hospital, Cardiology department.
627 Rode road, Chermside, QLD 4032
Country 110919 0
Australia
Phone 110919 0
+61 7 31394000
Fax 110919 0
Email 110919 0
[email protected]
Contact person for scientific queries
Name 110920 0
Maryam Khorramshahi Bayat
Address 110920 0
The Prince Charles Hospital, Cardiology department.
627 Rode road, Chermside, QLD 4032
Country 110920 0
Australia
Phone 110920 0
+61 426950965
Fax 110920 0
Email 110920 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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
No additional documents have been identified.