Alkalinization by Urologists & Nephrologists

Study Overview
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Brief Summary
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Metabolic acidosis recovers a wide range of diseases in which an oral alkalinization could be useful. This therapeutic intervention has been said to increase extracellular volume leading to rising blood pressure. No prospective data has been published in clinical routine. Here, investigators propose to follow patients in which an oral alkalinization is indicated: blood pressure, body weight, and a clinical evaluation of the extracellular compartment will be performed at the beginning and during the follow-up of participants. The principal criterion of evaluation will be the variation in the extracellular compartment.

Detailed Description
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Metabolic acidosis recovers a wide range of diseases - chronic kidney diseases, nephrolithiasis, or others - in which an oral alkalinization could be useful. Oral alkalinization could be performed or by bicarbonate contained in alkaline-based waters or drug therapies or by citrate. This therapeutic intervention has been said to increase extracellular volume leading to rising blood pressure, especially due to the amount of daily sodium load. No prospective data has been published in clinical routine, studying its effects on extracellular volume nor the blood pressure control. Here, investigators propose to follow patients in which an oral alkalinization is indicated: blood pressure, body weight, and a clinical evaluation of the extracellular compartment will be performed at the beginning and during the follow-up of participants. Initial recorded data will be: age, gender, prescription (indication, kind of alkali therapy, volume and duration), body weight, body length, a clinical appreciation of the extracellular compartment, blood pressure, comorbidities, drug therapy, blood and urine composition. The recorded follow-up will be: the adherence to treatment, body weight, body length, a clinical appreciation of the extracellular compartment, blood pressure, adverse events, blood and urine composition. The principal criterion of evaluation will be the variation in the extracellular compartment.

Official Title
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Prospective Evaluation of Oral Alkalinization by Urologists and Nephrologists: Evolution of the Extracellular Compartment

Conditions
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Metabolic Acidosis, Nephrolithiasis, Extracellular Alteration, Blood Pressure, Body Weight

Intervention / Treatment
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* Drug: Alkali


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > or = to 18 years old in whom an oral alkalinization is indicated Exclusion Criteria: if the patient mentions its opposition to his/her enrollment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Clinical and biological evaluation before and after an oral alkalinization
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alkali<br>Patients in whom an oral alkalinization whatever the formulation | Drug: Alkali<br>* Oral intake of alkali therapy whatever the formulation (alkali-based water, powder or pharmaceutics)<br>* Other names: Citrate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extracellular compartment M3 | Evaluation of the extracellular compartment by a composite clinical outcome at M3 composed by: body weight (kg), blood pressure (in mmHg, systolic and diastolic), and the presence edema | At M3 (month 3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Natremia (mM) | Evaluation of the impact of oral alkali therapy on natremia (mM) | At M3 (month 3) | 
| Urine output (l/d) | Evaluation of the impact of oral alkali therapy on urine output (l/d) | At M3 (month 3) | 
| Extracellular compartment M6 | Evaluation of the extracellular compartment by a composite clinical outcome at M6 composed by: body weight (kg), blood pressure (in mmHg, systolic and diastolic), and the presence edema | At M6 (month 6) | 
| Kalemia (mM) | Evaluation of the impact of oral alkali therapy on kalemia (mM) | At M3 (month 3) | 
| Blood chloride (mM) | Evaluation of the impact of oral alkali therapy on blood chloride (mM) | At M3 (month 3) | 
| Bicarbonatemia (mM) | Evaluation of the impact of oral alkali therapy on bicarbonatemia (mM) | At M3 (month 3) | 
| Proteinemia (g/l) | Evaluation of the impact of oral alkali therapy on proteinemia (mM) | At M3 (month 3) | 
| Albuminemia (g/l) | Evaluation of the impact of oral alkali therapy on albuminemia (mM) | At M3 (month 3) | 
| Creatininemia (microM) | Evaluation of the impact of oral alkali therapy on creatininemia (mM) | At M3 (month 3) | 
| Natriuresis (mmol/d) | Evaluation of the impact of oral alkali therapy on natriuresis (mmol/d) | At M3 (month 3) | 
| Urine chloride (mmol/d) | Evaluation of the impact of oral alkali therapy on urine chloride (mmol/d) | At M3 (month 3) | 
| Proteinuria (g/d) | Evaluation of the impact of oral alkali therapy on proteinuria (g/d) | At M3 (month 3) | 
| Creatinuria (mmol/d) | Evaluation of the impact of oral alkali therapy on creatinuria (mmol/d) | At M3 (month 3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bicarbonate