Clinical trial NCT03035812: Alkalinization by Urologists & Nephrologists
Official title: Prospective Evaluation of Oral Alkalinization by Urologists and Nephrologists: Evolution of the Extracellular Compartment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Metabolic Acidosis
Nephrolithiasis
Extracellular Alteration
Blood Pressure
Body Weight
Keywords: Bicarbonate
Lead sponsor: Club des Jeunes Néphrologues
Sponsor class: OTHER
First posted: 2017-01-30
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Clinical and biological evaluation before and after an oral alkalinization
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Extracellular compartment M3
timeFrame: At M3 (month 3)
Secondary outcomes:
measure: Natremia (mM)
timeFrame: At M3 (month 3)
measure: Urine output (l/d)
timeFrame: At M3 (month 3)
measure: Extracellular compartment M6
timeFrame: At M6 (month 6)
measure: Kalemia (mM)
timeFrame: At M3 (month 3)
measure: Blood chloride (mM)
timeFrame: At M3 (month 3)
measure: Bicarbonatemia (mM)
timeFrame: At M3 (month 3)
measure: Proteinemia (g/l)
timeFrame: At M3 (month 3)
measure: Albuminemia (g/l)
timeFrame: At M3 (month 3)
measure: Creatininemia (microM)
timeFrame: At M3 (month 3)
measure: Natriuresis (mmol/d)
timeFrame: At M3 (month 3)
measure: Urine chloride (mmol/d)
timeFrame: At M3 (month 3)
measure: Proteinuria (g/d)
timeFrame: At M3 (month 3)
measure: Creatinuria (mmol/d)
timeFrame: At M3 (month 3)
Other outcomes:
Locations:
city: Bourgoin
country: France
facility: Centre Hospitalier Pierre Oudot - Bourgoin-Jallieu
city: Brest
country: France
facility: La Cavale Blanche Hospital
city: Chambéry
country: France
facility: CHMS Chambery
city: Grenoble
country: France
facility: University Hospital of Grenoble
city: Irigny
country: France
facility: Calydial
city: Le Mans
country: France
facility: E.C.H.O. (Expansion des Centres d'Hémodialyse de l'Ouest)
city: Marseille
country: France
facility: La Conception University Hospital, AP-HM
city: Marseille
country: France
facility: Institut Phocéen de Néphrologie, Clinique Bouchard
city: Nantes
country: France
facility: Uninversity Hospital of Nantes
city: Paris
country: France
facility: AURA Paris Plaisance
city: Paris
country: France
facility: European Georges Pompidou Hospital
city: Paris
country: France
facility: Tenon Hospital, AP-HP
city: Reims
country: France
facility: Maison Blanche Hospital
city: Rennes
country: France
facility: Rennes Hospital
city: Saint Malo
country: France
facility: Aub Sante
city: Strasbourg
country: France
facility: Clinic area
city: Strasbourg
country: France
facility: Clinique Sainte Anne
city: Toulon
country: France
facility: HIA Sainte-Anne
Study officials:
affiliation: Club des Jeunes Néphrologues
name: Julie Beaume, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.