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Alkalinization by Urologists & Nephrologists (AlcalUN)

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ClinicalTrials.gov Identifier: NCT03035812
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : May 10, 2018
Sponsor:
Information provided by (Responsible Party):
Jean-Philippe Bertocchio, Club des Jeunes Néphrologues

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
Metabolic Acidosis Nephrolithiasis Extracellular Alteration Blood Pressure Body Weight Drug: Alkali 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Clinical 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 : February 1, 2017
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035812


Contacts
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Contact: Julie Beaume, MD 33483162344 etude.alcalun@gmail.com
Contact: Jean-Philippe Bertocchio, MD, PhD 33156092866 jean-philippe.bertocchio@aphp.fr

Locations
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France
Centre Hospitalier Pierre Oudot - Bourgoin-Jallieu Recruiting
Bourgoin, France, 38300
Contact: Louis De Laforcade, MD    33469157000    ldelaforcade@gmail.com   
Principal Investigator: Louis De Laforcade, MD         
CHMS Chambery Recruiting
Chambéry, France
Contact: Camille Overs, MD       camille.overs@ch-metropole-savoie.fr   
University Hospital of Grenoble Recruiting
Grenoble, France
Contact: Camille Overs, MD       covers@chu-grenoble.fr   
Calydial Recruiting
Irigny, France
Contact: Salvatore Citarda, MD    33472390017    salvatore.citarda@calycial.org   
E.C.H.O. (Expansion des Centres d'Hémodialyse de l'Ouest) Recruiting
Le Mans, France, 72016
Contact: Guillaume Seret, MD    33243548383    gseret@echo-sante.com   
Principal Investigator: Guillaume Seret, MD         
Institut Phocéen de Néphrologie, Clinique Bouchard Recruiting
Marseille, France
Contact: Stanislas Bataille, MD    33491159410    bataille.stanislas@sfr.fr   
Uninversity Hospital of Nantes Recruiting
Nantes, France
Contact: Lucile Figueres, MD, PhD       lucile.figueres@chu-nantes.fr   
AURA Paris Plaisance Recruiting
Paris, France, 75014
Contact: Victor Gueutin, MD, MSc    33181696000    victor.gueutin@auraparis.org   
Principal Investigator: Victor Gueutin, MD, MSc         
European Georges Pompidou Hospital Recruiting
Paris, France, 75908
Contact: Jean-Philippe Bertocchio, MD, PhD    33156095625    jean-philippe.bertocchio@aphp.fr   
Contact: Armelle Jourry, Mrs    33156093969    armelle.jourry@aphp.fr   
Principal Investigator: Jean-Philippe Bertocchio, MD, PhD         
Sub-Investigator: Philippine Davis, MD         
Sub-Investigator: Hamza Ayari, MD         
Sub-Investigator: Marie-Lucile Figueres, MD         
Sub-Investigator: Charrel Linster, MD         
Tenon Hospital, AP-HP Recruiting
Paris, France
Contact: Yosu Luque, MD, PhD       yosu.luque@gmail.com   
Maison Blanche Hospital Recruiting
Reims, France
Contact: Antoine Braconnier, MD    33326787717    abraconnier@chu-reims.fr   
Rennes Hospital Recruiting
Rennes, France
Contact: Léonard Golbin, MD    33299289490    leonard.golbin@chu-rennes.fr   
Aub Sante Recruiting
Saint Malo, France, 35400
Contact: Thibault Dolley-Hitze, MD, MSc    33299806252    thibault.dolley-hitze@aub-sante.fr   
Principal Investigator: Thibault Dolley-Hitze, MD, MSc         
Sub-Investigator: Lisa Belaid, MD         
Clinic area Recruiting
Strasbourg, France
Contact: Clotilde Muller, MD       clotilde-muller@hotmail.fr   
Clinique Sainte Anne Recruiting
Strasbourg, France
Contact: Clotilde Muller, MD    33388116768    clotilde-muller@hotmail.fr   
HIA Sainte-Anne Recruiting
Toulon, France, 83000
Contact: Julie Beaume, MD    33483162364    julie.beaume@gmail.com   
Principal Investigator: Julie Beaume, MD         
Sponsors and Collaborators
Jean-Philippe Bertocchio
Investigators
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Principal Investigator: Julie Beaume, MD Club des Jeunes Néphrologues

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Responsible Party: Jean-Philippe Bertocchio, President, Investigator, Club des Jeunes Néphrologues
ClinicalTrials.gov Identifier: NCT03035812     History of Changes
Other Study ID Numbers: AlcalUN
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jean-Philippe Bertocchio, Club des Jeunes Néphrologues:
Bicarbonate

Additional relevant MeSH terms:
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Body Weight
Acidosis
Nephrolithiasis
Kidney Calculi
Signs and Symptoms
Acid-Base Imbalance
Metabolic Diseases
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical