Alkalinization by Urologists & Nephrologists

Overview

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.

Full Title of Study: “Prospective Evaluation of Oral Alkalinization by Urologists and Nephrologists: Evolution of the Extracellular Compartment”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 21, 2020

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Alkali
    • Patients in whom an oral alkalinization whatever the formulation

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jean-Philippe Bertocchio
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Jean-Philippe Bertocchio, President, Investigator – Club des Jeunes Néphrologues
  • Overall Official(s)
    • Julie Beaume, MD, Principal Investigator, Club des Jeunes Néphrologues

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