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).

Cystinuria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03539926
• Other study ID #: DEV-LCD-01-17
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 9, 2018
• Est. completion date: February 2019

Study information

• Verified date: November 2018
• Source: Devicare S.L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: February 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cystinuria

Intervention

Device:
• Lit-control®pH Meter
Alkalinization products will be used as standard clinical practice together with the pH monitoring through the Lit-control®pH Meter.

Diagnostic Test:
• Reactive strips
Alkalinization products will be used as standard clinical practice together with the pH monitoring through the reactive strips.

Locations

Country	Name	City	State
Spain	Fundacio Puigvert	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Devicare S.L.	Clever Instruments S.L., Fundacio Puigvert

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of days with pH levels within range 7 and 8, during 6 months of home self-monitoring.	Urinary pH measurement	183 measurements (morning) in 6 months.
Primary	Percentage of days with pH levels within range 7 and 8, during 6 months of home self-monitoring.	Urinary pH measurement	183 measurements (afternoon) in 6 months.
Primary	Measurement of the volume of crystalluria.	volume of crystalluria	1 measurement at the moment of enrollment
Primary	Measurement of the volume of crystalluria.	volume of crystalluria	1 measurement at 6 months
Primary	Blood: DNA extraction.	Extraction of DNA for genetic study of mutations for cystinuria.	1 measurement at the moment of enrollment
Primary	Sediment analysis for the determination of urinary infection.	Sediment analysis for the determination of Ulcer Index (UI)	1 measurement at the moment of enrollment
Primary	Sediment analysis for the determination of urinary infection.	Sediment analysis for the determination of UI	1 measurement at 6 months
Primary	Total time within the margins established as safe in the pH control (months).	Amount of time within the pH margins established as safe	1 measurement through study completion [up to 6 months]
Primary	Adherence level in pH measurements	% compliance of the pH measurements	Through study completion, fraction of pH measurements on the total possible. [up to 6 months]
Primary	Adherence level to treatment	% of the intakes of the medication.	Through study completion, fraction of intakes on the total possible. [up to 6 months]
Primary	Total number of adverse events reported.	Amount of adverse events reported	Through study completion, number of events. [up to 6 months]
Primary	Blood Analysis. Glucose	Glucose in mmol/L	Change from Baseline measurement at 6 months
Primary	Blood Analysis. Calcium phosphate	calcium phosphate in µmol/L	Change from Baseline measurement at 6 months
Primary	Blood Analysis. Estimated Glomolecular Filtration Chronic Kidney Disease Epidemiology Collaboration (FG CKD-EPI)	estimated FG CKD-EPI	Change from Baseline measurement at 6 months
Primary	Blood Analysis. Cystatin	cystatin in mg/L (to be measured only if estimated FG> 45 or	Change from Baseline measurement at 6 months
Primary	Blood Analysis. Creatinine	creatinine in µmol/L	Change from Baseline measurement at 6 months
Primary	Blood Analysis. Urate	urate in µmol/L	Change from Baseline measurement at 6 months
Primary	24h Urine Analysis. Weight	Weight in kg	Change from Baseline measurement at 6 months
Primary	24h Urine Analysis. Size	Size in m	Change from Baseline measurement at 6 months
Primary	24h Urine Analysis. Urinary volume	Urinary volume in L	Change from Baseline measurement at 6 months
Primary	24h Urine Analysis. Calcium phosphate	calcium phosphate in µmol/L	Change from Baseline measurement at 6 months
Primary	24h Urine Analysis. Citrate	citrate in µmol/L	Change from Baseline measurement at 6 months
Primary	24h Urine Analysis. Urate	urate in µmol/L	Change from Baseline measurement at 6 months
Primary	24h Urine Analysis. Magnesium	magnesium in µmol/L	Change from Baseline measurement at 6 months
Primary	24h Urine Analysis. Sodium	sodium in µmol/L	Change from Baseline measurement at 6 months
Primary	24h Urine Analysis. BMI	weight and height will be combined to report BMI in kg/m^2	Change from Baseline measurement at 6 months
Primary	24h Urine Analysis. Potassium	potassium in µmol/L	Change from Baseline measurement at 6 months
Primary	24h Urine Analysis. Urea	urea in µmol/L	Change from Baseline measurement at 6 months
Primary	Urine for the study of crystalluria. Schedule	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.	Change from Baseline measurement at 6 months
Primary	Urine for the study of crystalluria. Crystalline volume	overall crystalline volume (µm3 / mL)	Change from Baseline measurement at 6 months
Primary	Urine for the study of crystalluria. Crystals	type and number of crystals (crystals / µL)	Change from Baseline measurement at 6 months
Primary	Urine for the study of crystalluria. Urine volume	urine volume in L	Change from Baseline measurement at 6 months
Primary	Urine for the study of crystalluria. pH	pH	Change from Baseline measurement at 6 months
Primary	Urine for the study of crystalluria. Size	size in µm	Change from Baseline measurement at 6 months
Primary	Urine for the study of crystalluria. Density	Density in mg / mL.	Change from Baseline measurement at 6 months
Primary	Urine for the study of crystalluria. Aggregation	aggregation	Change from Baseline measurement at 6 months
Primary	Urine for the study of crystalluria. Twinning	twinning	Change from Baseline measurement at 6 months
Primary	Urine for the study of crystalluria. Quotient	Quotient albumin / creatinine	Change from Baseline measurement at 6 months
Secondary	Sociodemographic and anthropometric questionnaire.	Family and personal background and general data (sex, age, etc.).	1 day of enrollment
Secondary	Patient satisfaction questionnaire with the pH measurement method	Visual Analogue Scale ranging from 1 (very dissatisfied) to 10 (very satisfied)	3 times in 6 months
Secondary	Physician satisfaction questionnaire with the pH measurement method	Likert Scale with 4 categories: very dissatisfied, dissatisfied, satisfied, very satisfied	3 times in 6 months