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Trial registered on ANZCTR


Registration number
ACTRN12623000129684
Ethics application status
Approved
Date submitted
20/12/2022
Date registered
7/02/2023
Date last updated
7/02/2023
Date data sharing statement initially provided
7/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized control trial: The role of an alkalinising agent (potassium citrate) in paediatric urinary tract infection (UTI)
Scientific title
The role of urinary alkaliniser, potassium citrate in treatment of pediatric (aged 1 month to 18 years old) UTIs and to compare the outcomes in term of duration of hospital stay, time to achieve resolution of the symptoms and change in clinical septic parameters with placebo group (drinking water) 
Secondary ID [1] 308644 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary Tract Infection 328563 0
Condition category
Condition code
Infection 325579 325579 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2-center, double blinded randomized controlled trial involving paediatric inpatient aged 1 month to 18 years old with acute UTI or/and recurrent UTI during their first or subsequent visit to hospital

Potassium citrate is used for the treatment of symptoms of UTI. This study aim to compare:
• Potassium citrate versus placebo (drinking water).

Half of the study participants will receive the alkaliniser agent (potassium citrate) while the other half of the participants will receive placebo (drinking water) on top of the standard care of management of UTI which include antibiotics and antipyretic.

The potassium citrate used in Hospital Universiti Sains Malaysia (HUSM) and Hospital Sultanah Nur Zahirah (HSNZ) were similar in term of the contents and solutions used. Both were colourless. In each 10 mls of potassium citrate contains 3 grams potassium citrate and 0.5 grams citric acid monohydrates (each 1 ml provides 2.8 mmol of potassium, 0.9 mmol of citrate and an equivalent of 2.8 mmol of bicarbonate).

Dosage of potassium citrate for all ages will vary over a range of 0.5 – 1 mmol citrate/kg/day in 3 divided doses for 5 days within weight strata to simplify medication administration and reduce potential dosing errors (Guy’s and St Thomas’ Paediatric formulary). It is given via orally and the progress of patients are observed within 5 to 7 days.
Intervention code [1] 325115 0
Treatment: Drugs
Comparator / control treatment
The control group will be given drinking water similar amount to the measured of the potassium citrate in 3 doses per day for 5 days.

The progress of patients are observed within 5 to 7 days.
Control group
Placebo

Outcomes
Primary outcome [1] 333424 0
Urine pH
- assessed using urinalysis
Timepoint [1] 333424 0
to assess the parameters on admission (pre-treatment) and 48 hours (post commencement of treatment)
Primary outcome [2] 333524 0
Time to achieve resolution of the symptoms
- assessed using patient medical records
Timepoint [2] 333524 0
progress of patients are observed at 5, 6 and 7 days post-commencement of treatment
Primary outcome [3] 333525 0
Duration of hospital stay
- assessed using patient medical records
Timepoint [3] 333525 0
Progress of patients are observed at 5, 6 and 7 days post-commencement of treatment
Secondary outcome [1] 417034 0
This is an additional of primary outcome

Change in septic parameters (CRP and procalcitonin) and bacterial load
(repeated urine culture after 48 hours)
Timepoint [1] 417034 0
these parameters are assessed as a composite and to assess the parameters on admission (pre-treatment) and 48 hours (post commencement of treatment)
Secondary outcome [2] 417418 0
Participant adherence to the study medications
- assessed using patient medical report
Timepoint [2] 417418 0
Progress of patients are observed at 5, 6 and 7 days post-commencement of treatment
Secondary outcome [3] 417419 0
The incidence of any adverse events - gastrointestinal upset, allergic reaction
- assessed using patient medical record
Timepoint [3] 417419 0
Progress of patients are observed at 5, 6 and 7 days post-commencement of treatment
Secondary outcome [4] 417420 0
Causative organisms
- assessed using urine culture
Timepoint [4] 417420 0
Urine culture taken on admission and 48 hours post commencement of treatment if there was growth documented

Eligibility
Key inclusion criteria
• Age 1 month to 18 years old at diagnosis
• All inpatients diagnosed with acute UTI or/and recurrent UTI during their first or subsequent visit to hospital

Minimum age
1 Months
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patient who had been treated with antibiotics less than 72 hours before presentation
• Patient who is allergic to potassium citrate
• Patient with underlying chronic renal failure, untreated Addison disease as well as patient who is on potassium sparing agent
• Patient who previously already recruited in the study

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)
The participants will be allocated into intervention or control group by using opaque, sealed and stapled envelopes which contained the group assignment.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The participants who fulfilled the inclusion criteria at admission were randomized into 2 groups by using computer generated block randomization prepared by investigator with no clinical involvement in the trial
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
There has been no study on the alkalinizing agent used in pediatric UTI. However, based on study by Ueda et al in 2013 reported that the changes of symptoms (pain or discomfort) following urine alkalinisation therapy were significantly greater compared with the group with low urine pH with standard deviation of pre and post treatment of 6.8 and 3.6 and difference of 3.2. Thus, a sample size of at least 27 participants each group is enough to achieve a power of 80% and a statistical significance of 5%. Taking into account of the possibility of 10% drop out rate, we estimate total sample of 30 in each arm (total 60 for both arms).


The data collected were analysed using the Statistical Package for the Social Science (SPSS) version 26. Analysis was by intention to treat.

The baseline characteristics of the groups were tabulated in table form and analysed using the descriptive statistics, reported as count (percent) for categorical variables, and mean (standard deviation) or median (interquartile range) for continuous variables, depending on the distribution. Descriptive statistics were examined for all variables under study.

Duration of hospital stay and time to achieve the resolution of the symptoms were analysed using Kaplan-Meier curve. Improvement of septic parameters, bacterial eradication and incidence of any adverse event were analysed using Chi-Square test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/02/2023
Actual
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
7/01/2024
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 25190 0
Malaysia
State/province [1] 25190 0
KELANTAN and TERENGGANU

Funding & Sponsors
Funding source category [1] 312877 0
University
Name [1] 312877 0
Universiti Sains Malaysia
Country [1] 312877 0
Malaysia
Primary sponsor type
University
Name
Universiti Sains Malaysia
Address
Kampus Kesihatan,
Universiti Sains Malaysia,
Jalan Raja Perempuan Zainab 2,
Kubang Kerian, 16150 Kota Bharu, Kelantan
Country
Malaysia
Secondary sponsor category [1] 314559 0
None
Name [1] 314559 0
Address [1] 314559 0
Country [1] 314559 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312155 0
Human Research Ethics Committee USM (HREC)
Ethics committee address [1] 312155 0
Kampus Kesihatan,
Universiti Sains Malaysia,
Jalan Raja Perempuan Zainab 2,
Kubang Kerian, 16150 Kota Bharu, Kelantan
Ethics committee country [1] 312155 0
Malaysia
Date submitted for ethics approval [1] 312155 0
07/06/2022
Approval date [1] 312155 0
22/11/2022
Ethics approval number [1] 312155 0
USM/JEPeM/22060352

Summary
Brief summary
This study is a 2-center, double blinded randomized control trial, involving all pediatric patients age 1 month to 18 years old with acute UTI or/and recurrent UTI. This study aims to study the benefits of urinary alkaliniser (potassium citrate) in management of pediatrics UTIs, to compare the outcomes with the control group (drinking water) in term of time to achieve resolution of the symptoms, duration of hospital stay and improvement of clinical septic parameters and the organisms causing pediatric UTIs. The total participants to be recruited about 60 participants.
The randomization is done by using computer generated block randomization and the participants will be allocated into intervention or control group by using opaque, sealed and stapled envelopes which contained the group assignment.
All the data collected were analysed using the Statistical Package for the Social Science (SPSS) version 26. Analysis was by intention to treat.
The baseline characteristics of the groups were tabulated in table form and analysed using the descriptive statistics, reported as count (percent) for categorical variables, and mean (standard deviation) or median (interquartile range) for continuous variables, depending on the distribution. Descriptive statistics were examined for all variables under study.

Duration of hospital stay and time to achieve the resolution of the symptoms were analysed using Kaplan-Meier curve. Improvement of septic parameters, bacterial eradication and incidence of any adverse event were analysed using Chi-Square test.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123670 0
Dr QUEK SIEW LUN
Address 123670 0
Kampus Kesihatan,
Universiti Sains Malaysia,
Jalan Raja Perempuan Zainab 2,
Kubang Kerian, 16150 Kota Bharu, Kelantan
Country 123670 0
Malaysia
Phone 123670 0
+60139011682
Fax 123670 0
Email 123670 0
xiu_lune@student.usm.my
Contact person for public queries
Name 123671 0
Dr QUEK SIEW LUN
Address 123671 0
Kampus Kesihatan,
Universiti Sains Malaysia,
Jalan Raja Perempuan Zainab 2,
Kubang Kerian, 16150 Kota Bharu, Kelantan
Country 123671 0
Malaysia
Phone 123671 0
+60139011682
Fax 123671 0
Email 123671 0
xiu_lune@student.usm.my
Contact person for scientific queries
Name 123672 0
Dr QUEK SIEW LUN
Address 123672 0
Kampus Kesihatan,
Universiti Sains Malaysia,
Jalan Raja Perempuan Zainab 2,
Kubang Kerian, 16150 Kota Bharu, Kelantan
Country 123672 0
Malaysia
Phone 123672 0
+60139011682
Fax 123672 0
Email 123672 0
xiu_lune@student.usm.my

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All forms are anonymous and will be entered the relevant software. Only research team members can access the data. Data will be presented as grouped data and will not identify the responders individually.


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.