Alkalinization by Urologists & Nephrologists (AlcalUN)

July 13, 2020 updated by: Jean-Philippe Bertocchio

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

156

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bourgoin, France, 38300
        • Centre Hospitalier Pierre Oudot - Bourgoin-Jallieu
      • Brest, France, 29600
        • La Cavale Blanche Hospital
      • Chambéry, France
        • CHMS Chambery
      • Grenoble, France
        • University hospital of Grenoble
      • Irigny, France
        • Calydial
      • Le Mans, France, 72016
        • E.C.H.O. (Expansion des Centres d'Hémodialyse de l'Ouest)
      • Marseille, France, 13005
        • La Conception University Hospital, AP-HM
      • Marseille, France
        • Institut Phocéen de Néphrologie, Clinique Bouchard
      • Nantes, France
        • Uninversity Hospital of Nantes
      • Paris, France, 75014
        • AURA Paris Plaisance
      • Paris, France, 75908
        • European Georges Pompidou Hospital
      • Paris, France
        • Tenon Hospital, AP-HP
      • Reims, France
        • MAISON BLANCHE Hospital
      • Rennes, France
        • Rennes Hospital
      • Saint Malo, France, 35400
        • Aub Sante
      • Strasbourg, France
        • Clinique Sainte Anne
      • Strasbourg, France
        • Clinic Area
      • Toulon, France, 83000
        • HIA Sainte-Anne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alkali
Patients in whom an oral alkalinization whatever the formulation
Drug: Alkali
Oral intake of alkali therapy whatever the formulation (alkali-based water, powder or pharmaceutics)
Other Names:
  • Citrate
  • Bicarbonate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extracellular compartment M3
Time Frame: 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
At M3 (month 3)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jean-Philippe Bertocchio

Investigators

  • Principal Investigator: Julie Beaume, MD, Club des Jeunes Néphrologues

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

February 21, 2020

Study Completion (Actual)

February 21, 2020

Study Registration Dates

First Submitted

January 26, 2017

First Submitted That Met QC Criteria

January 26, 2017

First Posted (Estimate)

January 30, 2017

Study Record Updates

Last Update Posted (Actual)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 13, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AlcalUN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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