Alkalinization by Urologists & Nephrologists

Blood Pressure Clinical Trial

— AlcalUN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03035812
• Other study ID #: AlcalUN
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2017
• Est. completion date: February 21, 2020

Study information

• Verified date: July 2020
• Source: Club des Jeunes Néphrologues
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: February 21, 2020
• Est. primary completion date: February 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
France	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	Institut Phocéen de Néphrologie, Clinique Bouchard	Marseille
France	La Conception University Hospital, AP-HM	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	Saint Malo
France	Clinic area	Strasbourg
France	Clinique Sainte Anne	Strasbourg
France	HIA Sainte-Anne	Toulon

Sponsors (1)

Lead Sponsor	Collaborator
Jean-Philippe Bertocchio

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	Natremia (mM)	Evaluation of the impact of oral alkali therapy on natremia (mM)	At M3 (month 3)
Secondary	Urine output (l/d)	Evaluation of the impact of oral alkali therapy on urine output (l/d)	At M3 (month 3)
Secondary	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)
Secondary	Kalemia (mM)	Evaluation of the impact of oral alkali therapy on kalemia (mM)	At M3 (month 3)
Secondary	Blood chloride (mM)	Evaluation of the impact of oral alkali therapy on blood chloride (mM)	At M3 (month 3)
Secondary	Bicarbonatemia (mM)	Evaluation of the impact of oral alkali therapy on bicarbonatemia (mM)	At M3 (month 3)
Secondary	Proteinemia (g/l)	Evaluation of the impact of oral alkali therapy on proteinemia (mM)	At M3 (month 3)
Secondary	Albuminemia (g/l)	Evaluation of the impact of oral alkali therapy on albuminemia (mM)	At M3 (month 3)
Secondary	Creatininemia (microM)	Evaluation of the impact of oral alkali therapy on creatininemia (mM)	At M3 (month 3)
Secondary	Natriuresis (mmol/d)	Evaluation of the impact of oral alkali therapy on natriuresis (mmol/d)	At M3 (month 3)
Secondary	Urine chloride (mmol/d)	Evaluation of the impact of oral alkali therapy on urine chloride (mmol/d)	At M3 (month 3)
Secondary	Proteinuria (g/d)	Evaluation of the impact of oral alkali therapy on proteinuria (g/d)	At M3 (month 3)
Secondary	Creatinuria (mmol/d)	Evaluation of the impact of oral alkali therapy on creatinuria (mmol/d)	At M3 (month 3)