Alkalinization by Urologists & Nephrologists

Phase 4

Completed

• Conditions: Metabolic Acidosis; Extracellular Alteration; Nephrolithiasis; Blood Pressure; Body Weight
• Interventions: Drug: Alkali

• Registration Number: NCT03035812
• Lead Sponsor: Jean-Philippe Bertocchio

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.

Study Timeline

• Study First Submitted: 2017-01-26
• Study First Submitted QC: 2017-01-26
• Study First Posted: 2017-01-30
• Study Start: 2017-02-01
• Primary Completion: 2020-02-21
• Study Completion: 2020-02-21
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-13
• Last Update Posted: 2020-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Alkali	Alkali	Patients in whom an oral alkalinization whatever the formulation

Primary Outcome Measures

Name	Time	Method
Extracellular compartment M3	At M3 (month 3)	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

Secondary Outcome Measures

Name	Time	Method
Proteinemia (g/l)	At M3 (month 3)	Evaluation of the impact of oral alkali therapy on proteinemia (mM)
Albuminemia (g/l)	At M3 (month 3)	Evaluation of the impact of oral alkali therapy on albuminemia (mM)
Urine chloride (mmol/d)	At M3 (month 3)	Evaluation of the impact of oral alkali therapy on urine chloride (mmol/d)
Proteinuria (g/d)	At M3 (month 3)	Evaluation of the impact of oral alkali therapy on proteinuria (g/d)
Natremia (mM)	At M3 (month 3)	Evaluation of the impact of oral alkali therapy on natremia (mM)
Urine output (l/d)	At M3 (month 3)	Evaluation of the impact of oral alkali therapy on urine output (l/d)
Extracellular compartment M6	At M6 (month 6)	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
Kalemia (mM)	At M3 (month 3)	Evaluation of the impact of oral alkali therapy on kalemia (mM)
Bicarbonatemia (mM)	At M3 (month 3)	Evaluation of the impact of oral alkali therapy on bicarbonatemia (mM)
Natriuresis (mmol/d)	At M3 (month 3)	Evaluation of the impact of oral alkali therapy on natriuresis (mmol/d)
Blood chloride (mM)	At M3 (month 3)	Evaluation of the impact of oral alkali therapy on blood chloride (mM)
Creatininemia (microM)	At M3 (month 3)	Evaluation of the impact of oral alkali therapy on creatininemia (mM)
Creatinuria (mmol/d)	At M3 (month 3)	Evaluation of the impact of oral alkali therapy on creatinuria (mmol/d)

Trial Locations

Locations (18)

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

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