None listed
Conditions
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.
Interventions
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 (drink
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.
Sponsors
Universiti Sains Malaysia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
1 Months to 18 Years
Healthy volunteers
No
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
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
Outcome results
None listed