Cystinuria
Conditions
Keywords
Cystinuria, pH Control
Brief summary
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).
Detailed description
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.
Interventions
DEVICELit-control®pH Meter
Alkalinization products will be used as standard clinical practice together with the pH monitoring through the Lit-control®pH Meter.
DIAGNOSTIC_TESTReactive strips
Alkalinization products will be used as standard clinical practice together with the pH monitoring through the reactive strips.
Sponsors
Clever Instruments S.L.
Fundacio Puigvert
Devicare S.L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Masking description
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.
Intervention model description
Patients will receive the product for home pH monitoring, but they will keep following the doctor's recommendations indicated in the usual clinical practice. The proportion of patients will be 1: 1 between the study group (Lit-control®pH Meter) and the control group (test strips).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Patients with pathologies that require pH control other than the one established in the study protocol to avoid the formation of kidney stones.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urine for the study of crystalluria. Quotient | Change from Baseline measurement at 6 months | Quotient albumin / creatinine |
| Urine for the study of crystalluria. Density | Change from Baseline measurement at 6 months | Density in mg / mL. |
| Urine for the study of crystalluria. Aggregation | Change from Baseline measurement at 6 months | aggregation |
| Urine for the study of crystalluria. Twinning | Change from Baseline measurement at 6 months | twinning |
| Urine for the study of crystalluria. Urine volume | Change from Baseline measurement at 6 months | urine volume in L |
| Percentage of days with pH levels within range 7 and 8, during 6 months of home self-monitoring. | 183 measurements (morning) in 6 months. | Urinary pH measurement |
| Measurement of the volume of crystalluria. | 1 measurement at the moment of enrollment | volume of crystalluria |
| Urine for the study of crystalluria. Crystals | Change from Baseline measurement at 6 months | type and number of crystals (crystals / μL) |
| Blood: DNA extraction. | 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. | 1 measurement at the moment of enrollment | Sediment analysis for the determination of Ulcer Index (UI) |
| Total time within the margins established as safe in the pH control (months). | 1 measurement through study completion [up to 6 months] | Amount of time within the pH margins established as safe |
| Adherence level in pH measurements | Through study completion, fraction of pH measurements on the total possible. [up to 6 months] | % compliance of the pH measurements |
| Adherence level to treatment | Through study completion, fraction of intakes on the total possible. [up to 6 months] | % of the intakes of the medication. |
| Total number of adverse events reported. | Through study completion, number of events. [up to 6 months] | Amount of adverse events reported |
| Blood Analysis. Glucose | Change from Baseline measurement at 6 months | Glucose in mmol/L |
| Blood Analysis. Calcium phosphate | Change from Baseline measurement at 6 months | calcium phosphate in µmol/L |
| Blood Analysis. Estimated Glomolecular Filtration Chronic Kidney Disease Epidemiology Collaboration (FG CKD-EPI) | Change from Baseline measurement at 6 months | estimated FG CKD-EPI |
| Blood Analysis. Cystatin | 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) |
| Blood Analysis. Creatinine | Change from Baseline measurement at 6 months | creatinine in µmol/L |
| Blood Analysis. Urate | Change from Baseline measurement at 6 months | urate in μmol/L |
| 24h Urine Analysis. Weight | Change from Baseline measurement at 6 months | Weight in kg |
| 24h Urine Analysis. Size | Change from Baseline measurement at 6 months | Size in m |
| 24h Urine Analysis. Urinary volume | Change from Baseline measurement at 6 months | Urinary volume in L |
| 24h Urine Analysis. Calcium phosphate | Change from Baseline measurement at 6 months | calcium phosphate in µmol/L |
| 24h Urine Analysis. Citrate | Change from Baseline measurement at 6 months | citrate in μmol/L |
| 24h Urine Analysis. Urate | Change from Baseline measurement at 6 months | urate in μmol/L |
| 24h Urine Analysis. Magnesium | Change from Baseline measurement at 6 months | magnesium in μmol/L |
| 24h Urine Analysis. Sodium | Change from Baseline measurement at 6 months | sodium in μmol/L |
| 24h Urine Analysis. BMI | Change from Baseline measurement at 6 months | weight and height will be combined to report BMI in kg/m\^2 |
| 24h Urine Analysis. Potassium | Change from Baseline measurement at 6 months | potassium in μmol/L |
| 24h Urine Analysis. Urea | Change from Baseline measurement at 6 months | urea in µmol/L |
| Urine for the study of crystalluria. Schedule | 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. |
| Urine for the study of crystalluria. Crystalline volume | Change from Baseline measurement at 6 months | overall crystalline volume (μm3 / mL) |
| Urine for the study of crystalluria. pH | Change from Baseline measurement at 6 months | pH |
| Urine for the study of crystalluria. Size | Change from Baseline measurement at 6 months | size in μm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction questionnaire with the pH measurement method | 3 times in 6 months | Visual Analogue Scale ranging from 1 (very dissatisfied) to 10 (very satisfied) |
| Physician satisfaction questionnaire with the pH measurement method | 3 times in 6 months | Likert Scale with 4 categories: very dissatisfied, dissatisfied, satisfied, very satisfied |
| Sociodemographic and anthropometric questionnaire. | 1 day of enrollment | Family and personal background and general data (sex, age, etc.). |
Countries
Spain
Outcome results
None listed