Alkalinization by Urologists & Nephrologists (AlcalUN)

Jean-Philippe Bertocchio

Status and phase: Completed; Phase 4

Conditions: Extracellular Alteration; Metabolic Acidosis; Body Weight; Nephrolithiasis; Blood Pressure

Treatments: Drug: Alkali

Study type: Interventional

Funder types: Other

Identifiers

NCT03035812

AlcalUN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 156 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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156 participants in 1 patient group

Alkali

Experimental group

Description:

Patients in whom an oral alkalinization whatever the formulation

Treatment:

Drug: Alkali