Blood Pressure, Body Weight, Extracellular Alteration, Metabolic Acidosis, Nephrolithiasis
Conditions
Keywords
Bicarbonate
Brief summary
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
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.
Interventions
DRUGAlkali
Oral intake of alkali therapy whatever the formulation (alkali-based water, powder or pharmaceutics)
Sponsors
Jean-Philippe Bertocchio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Clinical and biological evaluation before and after an oral alkalinization
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extracellular compartment M3 | At M3 (month 3) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urine output (l/d) | At M3 (month 3) | Evaluation of the impact of oral alkali therapy on urine output (l/d) |
| Extracellular compartment M6 | At M6 (month 6) | 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 |
| Kalemia (mM) | At M3 (month 3) | Evaluation of the impact of oral alkali therapy on kalemia (mM) |
| Blood chloride (mM) | At M3 (month 3) | Evaluation of the impact of oral alkali therapy on blood chloride (mM) |
| Bicarbonatemia (mM) | At M3 (month 3) | Evaluation of the impact of oral alkali therapy on bicarbonatemia (mM) |
| Proteinemia (g/l) | At M3 (month 3) | Evaluation of the impact of oral alkali therapy on proteinemia (mM) |
| Natremia (mM) | At M3 (month 3) | Evaluation of the impact of oral alkali therapy on natremia (mM) |
| Creatininemia (microM) | At M3 (month 3) | Evaluation of the impact of oral alkali therapy on creatininemia (mM) |
| Natriuresis (mmol/d) | At M3 (month 3) | Evaluation of the impact of oral alkali therapy on natriuresis (mmol/d) |
| Urine chloride (mmol/d) | At M3 (month 3) | Evaluation of the impact of oral alkali therapy on urine chloride (mmol/d) |
| Proteinuria (g/d) | At M3 (month 3) | Evaluation of the impact of oral alkali therapy on proteinuria (g/d) |
| Creatinuria (mmol/d) | At M3 (month 3) | Evaluation of the impact of oral alkali therapy on creatinuria (mmol/d) |
| Albuminemia (g/l) | At M3 (month 3) | Evaluation of the impact of oral alkali therapy on albuminemia (mM) |
Countries
France
Outcome results
None listed