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AlcalUN: Alkalinization by Urologists & Nephrologists

Sponsor
Jean-Philippe Bertocchio (Other)
Overall Status
Completed
CT.gov ID
NCT03035812
Collaborator
(none)
156
Enrollment
18
Locations
1
Arm
36.6
Actual Duration (Months)
8.7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
156 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Clinical and biological evaluation before and after an oral alkalinizationClinical and biological evaluation before and after an oral alkalinization
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective Evaluation of Oral Alkalinization by Urologists and Nephrologists: Evolution of the Extracellular Compartment
Actual Study Start Date :
Feb 1, 2017
Actual Primary Completion Date :
Feb 21, 2020
Actual Study Completion Date :
Feb 21, 2020

Arms and Interventions

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:
  • Bicarbonate
  • Citrate

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Natremia (mM) [At M3 (month 3)]

      Evaluation of the impact of oral alkali therapy on natremia (mM)

    2. Urine output (l/d) [At M3 (month 3)]

      Evaluation of the impact of oral alkali therapy on urine output (l/d)

    3. 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

    4. Kalemia (mM) [At M3 (month 3)]

      Evaluation of the impact of oral alkali therapy on kalemia (mM)

    5. Blood chloride (mM) [At M3 (month 3)]

      Evaluation of the impact of oral alkali therapy on blood chloride (mM)

    6. Bicarbonatemia (mM) [At M3 (month 3)]

      Evaluation of the impact of oral alkali therapy on bicarbonatemia (mM)

    7. Proteinemia (g/l) [At M3 (month 3)]

      Evaluation of the impact of oral alkali therapy on proteinemia (mM)

    8. Albuminemia (g/l) [At M3 (month 3)]

      Evaluation of the impact of oral alkali therapy on albuminemia (mM)

    9. Creatininemia (microM) [At M3 (month 3)]

      Evaluation of the impact of oral alkali therapy on creatininemia (mM)

    10. Natriuresis (mmol/d) [At M3 (month 3)]

      Evaluation of the impact of oral alkali therapy on natriuresis (mmol/d)

    11. Urine chloride (mmol/d) [At M3 (month 3)]

      Evaluation of the impact of oral alkali therapy on urine chloride (mmol/d)

    12. Proteinuria (g/d) [At M3 (month 3)]

      Evaluation of the impact of oral alkali therapy on proteinuria (g/d)

    13. Creatinuria (mmol/d) [At M3 (month 3)]

      Evaluation of the impact of oral alkali therapy on creatinuria (mmol/d)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre Hospitalier Pierre Oudot - Bourgoin-Jallieu Bourgoin France 38300
    2 La Cavale Blanche Hospital Brest France 29600
    3 CHMS Chambery Chambéry France
    4 University Hospital of Grenoble Grenoble France
    5 Calydial Irigny France
    6 E.C.H.O. (Expansion des Centres d'Hémodialyse de l'Ouest) Le Mans France 72016
    7 La Conception University Hospital, AP-HM Marseille France 13005
    8 Institut Phocéen de Néphrologie, Clinique Bouchard Marseille France
    9 Uninversity Hospital of Nantes Nantes France
    10 AURA Paris Plaisance Paris France 75014
    11 European Georges Pompidou Hospital Paris France 75908
    12 Tenon Hospital, AP-HP Paris France
    13 Maison Blanche Hospital Reims France
    14 Rennes Hospital Rennes France
    15 Aub Sante Saint Malo France 35400
    16 Clinic area Strasbourg France
    17 Clinique Sainte Anne Strasbourg France
    18 HIA Sainte-Anne Toulon France 83000

    Sponsors and Collaborators

    • Jean-Philippe Bertocchio

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jean-Philippe Bertocchio, President, Investigator, Club des Jeunes Néphrologues
    ClinicalTrials.gov Identifier:
    NCT03035812
    Other Study ID Numbers:
    • AlcalUN
    First Posted:
    Jan 30, 2017
    Last Update Posted:
    Jul 14, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jean-Philippe Bertocchio, President, Investigator, Club des Jeunes Néphrologues
    Bicarbonate
    Additional relevant MeSH terms:
    Nephrolithiasis
    Kidney Calculi
    Acidosis
    Body Weight

    Study Results

    No Results Posted as of Jul 14, 2020