Alkalinization by Urologists & Nephrologists

NCT ID: NCT03035812

Last Updated: 2020-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2020-02-21

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Alkali

Patients in whom an oral alkalinization whatever the formulation

Group Type: EXPERIMENTAL

Alkali

Intervention Type: DRUG

Oral intake of alkali therapy whatever the formulation (alkali-based water, powder or pharmaceutics)

Interventions

Alkali

Oral intake of alkali therapy whatever the formulation (alkali-based water, powder or pharmaceutics)

Intervention Type: DRUG

Other Intervention Names

Bicarbonate; Citrate

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jean-Philippe Bertocchio

OTHER

Sponsor Role: lead

Responsible Party

Jean-Philippe Bertocchio

President, Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Julie Beaume, MD

Role: PRINCIPAL_INVESTIGATOR

Club des Jeunes Néphrologues

Locations

Centre Hospitalier Pierre Oudot - Bourgoin-Jallieu

Bourgoin, , France

La Cavale Blanche Hospital

Brest, , 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, , France

La Conception University Hospital, AP-HM

Marseille, , France

Institut Phocéen de Néphrologie, Clinique Bouchard

Marseille, , France

Uninversity Hospital of Nantes

Nantes, , France

AURA Paris Plaisance

Paris, , France

European Georges Pompidou Hospital

Paris, , France

Tenon Hospital, AP-HP

Paris, , France

Maison Blanche Hospital

Reims, , France

Rennes Hospital

Rennes, , France

Aub Sante

St-Malo, , France

Clinic area

Strasbourg, , France

Clinique Sainte Anne

Strasbourg, , France

HIA Sainte-Anne

Toulon, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 34564842 (View on PubMed)

Other Identifiers

AlcalUN

Identifier Type: -

Identifier Source: org_study_id