NCT03035812

Alkalinization by Urologists & Nephrologists

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Jean-Philippe Bertocchio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metabolic Acidosis
• Nephrolithiasis
• Extracellular Alteration
• Blood Pressure
• Body Weight

Interventions

Type	Name	Description
DRUG	Alkali	Oral intake of alkali therapy whatever the formulation (alkali-based water, powder or pharmaceutics)

Timeline

• Start date: 2017-02-01
• Primary completion: 2020-02-21
• Completion: 2020-02-21
• First posted: 2017-01-30
• Last updated: 2020-07-14

Locations

18 sites across 1 country: France