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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alkali | Experimental | Patients in whom an oral alkalinization whatever the formulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alkali | Drug | Oral intake of alkali therapy whatever the formulation (alkali-based water, powder or pharmaceutics) |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie Beaume, MD | Club des Jeunes Néphrologues | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Pierre Oudot - Bourgoin-Jallieu | Bourgoin | 38300 | France | |||
| La Cavale Blanche Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34564842 | Derived | Beaume J, Figueres L, Bobot M, de Laforcade L, Ayari H, Dolley-Hitze T, Gueutin V, Braconnier A, Golbin L, Citarda S, Seret G, Belaid L, Cohen R, Luque Y, Larceneux F, Seervai RNH, Overs C, Bertocchio JP; Club des Jeunes Nephrologues. Sodium Bicarbonate Prescription and Extracellular Volume Increase: Real-world Data Results from the AlcalUN Study. Clin Pharmacol Ther. 2022 Jan;111(1):252-262. doi: 10.1002/cpt.2427. Epub 2021 Oct 11. |
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| ID | Term |
|---|---|
| D000138 | Acidosis |
| D053040 | Nephrolithiasis |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007674 | Kidney Diseases |
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| ID | Term |
|---|---|
| D000468 | Alkalies |
| D001639 | Bicarbonates |
| D019343 | Citric Acid |
| ID | Term |
|---|---|
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
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Clinical and biological evaluation before and after an oral alkalinization
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| 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) |
| Brest |
| 29600 |
| France |
| CHMS Chambery | Chambéry | France |
| University Hospital of Grenoble | Grenoble | France |
| Calydial | Irigny | France |
| E.C.H.O. (Expansion des Centres d'Hémodialyse de l'Ouest) | Le Mans | 72016 | France |
| La Conception University Hospital, AP-HM | Marseille | 13005 | France |
| Institut Phocéen de Néphrologie, Clinique Bouchard | Marseille | France |
| Uninversity Hospital of Nantes | Nantes | France |
| AURA Paris Plaisance | Paris | 75014 | France |
| European Georges Pompidou Hospital | Paris | 75908 | France |
| Tenon Hospital, AP-HP | Paris | France |
| Maison Blanche Hospital | Reims | France |
| Rennes Hospital | Rennes | France |
| Aub Sante | St-Malo | 35400 | France |
| Clinic area | Strasbourg | France |
| Clinique Sainte Anne | Strasbourg | France |
| HIA Sainte-Anne | Toulon | 83000 | France |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000838 |
| Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D002951 | Citrates |
| D014233 | Tricarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |