Randomized, Controlled and Opened Trial on the Impact of the Use of a pH-Meter on the Domiciliary Control of the Urinary pH as Adjuvant to the Treatment of Cystinuric Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Percentage of days with pH levels within range 7 and 8, during 6 months of home self-monitoring.
研究概览
简要总结
This study evaluates the superiority of daily self-pH monitorization of Lit-control®pH meter compared to the monitorization of reactive strips (standard of care).
详细描述
Cystinuria is a disease of autosomal recessive inheritance. This disease belongs to the so-called orphan diseases although its prevalence may change depending on the country.
It is known that urinary pH is a risk factor for the formation of cystine crystals because their solubility is pH-dependent. In different studies it has been shown that the solubility of cystine in urine increases when alkalinizing urinary pH, thus reducing the likelihood of crystal formation. Therefore, the control of urinary pH along with hygienic-dietetic measures that alkalize the urine or decrease the urinary concentration of cystine (abundant intake of water, food, etc.) are highly recommended as a preventive method to prevent the formation of cystine crystals whose retention and growth results in the formation of stones.
The Lit-control®pH Meter is a pH meter that allows a patient to self-monitor its urinary pH in a comfortable and simple way. With this tool the patient is able to know if his urinary pH is within the recommended limits. In other medical fields it has been observed that home monitoring of clinically relevant physiological parameters is a way of empowering the patient that can positively affect their attitudes and behaviors (adherence to received treatment, quality of life) and potentially improve their medical condition. Specifically, in patients with chronic diseases, the self-monitoring has been associated with a significant reduction in hospitalizations and hospital readmissions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
The process of randomization, either device use or use of strips, will be masked until the moment it is delivered to the patient. The random assignment to each product will be made through lists created by an ad hoc computer program.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old.
- •Cystinuric patients, with or without urinary lithiasis at the time of inclusion.
- •Patients who accept their participation in the study and give their informed consent.
排除标准
- •Patients with pathologies that require pH control other than the one established in the study protocol to avoid the formation of kidney stones.
研究组 & 干预措施
Lit-control®pH Meter
The control of the urinary pH will be carried out twice a day: with the first urine in the morning and in the evening-night (approximately every 12h and at the same time). Measurements will be performed using the Lit-control®pH Meter device.
干预措施: Lit-control®pH Meter (Device)
Reactive strips
The control of the urinary pH will be carried out twice a day: with the first urine in the morning and in the evening-night (approximately every 12h and at the same time). Measurements will be performed using the reactive strips.
干预措施: Reactive strips (Diagnostic Test)
结局指标
主要结局
Percentage of days with pH levels within range 7 and 8, during 6 months of home self-monitoring.
时间窗: 183 measurements (afternoon) in 6 months.
Urinary pH measurement
Measurement of the volume of crystalluria.
时间窗: 1 measurement at 6 months
volume of crystalluria
Adherence level in pH measurements
时间窗: Through study completion, fraction of pH measurements on the total possible. [up to 6 months]
% compliance of the pH measurements
Total number of adverse events reported.
时间窗: Through study completion, number of events. [up to 6 months]
Amount of adverse events reported
Blood Analysis. Glucose
时间窗: Change from Baseline measurement at 6 months
Glucose in mmol/L
Blood Analysis. Calcium phosphate
时间窗: Change from Baseline measurement at 6 months
calcium phosphate in µmol/L
Blood Analysis. Urate
时间窗: Change from Baseline measurement at 6 months
urate in μmol/L
24h Urine Analysis. Urinary volume
时间窗: Change from Baseline measurement at 6 months
Urinary volume in L
24h Urine Analysis. Calcium phosphate
时间窗: Change from Baseline measurement at 6 months
calcium phosphate in µmol/L
24h Urine Analysis. Citrate
时间窗: Change from Baseline measurement at 6 months
citrate in μmol/L
Blood: DNA extraction.
时间窗: 1 measurement at the moment of enrollment
Extraction of DNA for genetic study of mutations for cystinuria.
Sediment analysis for the determination of urinary infection.
时间窗: 1 measurement at 6 months
Sediment analysis for the determination of UI
Adherence level to treatment
时间窗: Through study completion, fraction of intakes on the total possible. [up to 6 months]
% of the intakes of the medication.
Blood Analysis. Creatinine
时间窗: Change from Baseline measurement at 6 months
creatinine in µmol/L
24h Urine Analysis. Weight
时间窗: Change from Baseline measurement at 6 months
Weight in kg
24h Urine Analysis. Urate
时间窗: Change from Baseline measurement at 6 months
urate in μmol/L
24h Urine Analysis. Sodium
时间窗: Change from Baseline measurement at 6 months
sodium in μmol/L
24h Urine Analysis. BMI
时间窗: Change from Baseline measurement at 6 months
weight and height will be combined to report BMI in kg/m\^2
Urine for the study of crystalluria. Schedule
时间窗: Change from Baseline measurement at 6 months
First urine of the morning (totality) for the study of crystalluria. Patient will provide the last hour of urination and hour of urine obtention in the morning.
Total time within the margins established as safe in the pH control (months).
时间窗: 1 measurement through study completion [up to 6 months]
Amount of time within the pH margins established as safe
Blood Analysis. Estimated Glomolecular Filtration Chronic Kidney Disease Epidemiology Collaboration (FG CKD-EPI)
时间窗: Change from Baseline measurement at 6 months
estimated FG CKD-EPI
Blood Analysis. Cystatin
时间窗: Change from Baseline measurement at 6 months
cystatin in mg/L (to be measured only if estimated FG\> 45 or \<ml /min / 1.73 m2 and albumin / creatinine in the urine \<3 mg / mmol)
24h Urine Analysis. Size
时间窗: Change from Baseline measurement at 6 months
Size in m
24h Urine Analysis. Magnesium
时间窗: Change from Baseline measurement at 6 months
magnesium in μmol/L
24h Urine Analysis. Potassium
时间窗: Change from Baseline measurement at 6 months
potassium in μmol/L
24h Urine Analysis. Urea
时间窗: Change from Baseline measurement at 6 months
urea in µmol/L
Urine for the study of crystalluria. pH
时间窗: Change from Baseline measurement at 6 months
pH
Urine for the study of crystalluria. Crystalline volume
时间窗: Change from Baseline measurement at 6 months
overall crystalline volume (μm3 / mL)
Urine for the study of crystalluria. Size
时间窗: Change from Baseline measurement at 6 months
size in μm
Urine for the study of crystalluria. Density
时间窗: Change from Baseline measurement at 6 months
Density in mg / mL.
Urine for the study of crystalluria. Crystals
时间窗: Change from Baseline measurement at 6 months
type and number of crystals (crystals / μL)
Urine for the study of crystalluria. Urine volume
时间窗: Change from Baseline measurement at 6 months
urine volume in L
Urine for the study of crystalluria. Aggregation
时间窗: Change from Baseline measurement at 6 months
aggregation
Urine for the study of crystalluria. Twinning
时间窗: Change from Baseline measurement at 6 months
twinning
Urine for the study of crystalluria. Quotient
时间窗: Change from Baseline measurement at 6 months
Quotient albumin / creatinine
次要结局
- Sociodemographic and anthropometric questionnaire.(1 day of enrollment)
- Patient satisfaction questionnaire with the pH measurement method(3 times in 6 months)
- Physician satisfaction questionnaire with the pH measurement method(3 times in 6 months)