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Completed

NCT Number: NCT03035812

Alkalinization by Urologists & Nephrologists

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre Hospitalier Pierre Oudot - Bourgoin-Jallieu, Bourgoin, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alkali

Drug

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

Other names: Bicarbonate, Citrate

Primary outcomes

  1. 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 outcomes

  1. Natremia (mM)

    Time frame: At M3 (month 3)

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

  2. Urine output (l/d)

    Time frame: At M3 (month 3)

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

  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

  4. Kalemia (mM)

    Time frame: At M3 (month 3)

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

  5. Blood chloride (mM)

    Time frame: At M3 (month 3)

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

  6. Bicarbonatemia (mM)

    Time frame: At M3 (month 3)

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

  7. Proteinemia (g/l)

    Time frame: At M3 (month 3)

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

  8. Albuminemia (g/l)

    Time frame: At M3 (month 3)

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

  9. Creatininemia (microM)

    Time frame: At M3 (month 3)

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

  10. Natriuresis (mmol/d)

    Time frame: At M3 (month 3)

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

  11. Urine chloride (mmol/d)

    Time frame: At M3 (month 3)

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

  12. Proteinuria (g/d)

    Time frame: At M3 (month 3)

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

  13. Creatinuria (mmol/d)

    Time frame: At M3 (month 3)

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

Sponsors and collaborators

Lead sponsor

Jean-Philippe Bertocchio

Other

Registry information

Official study title

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

Acronym: AlcalUN

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 30, 2017
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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