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Alkalinization by Urologists & Nephrologists (AlcalUN)

Primary Purpose

Metabolic Acidosis, Nephrolithiasis, Extracellular Alteration

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Alkali
Sponsored by
Jean-Philippe Bertocchio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Acidosis focused on measuring Bicarbonate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Pierre Oudot - Bourgoin-Jallieu
  • La Cavale Blanche Hospital
  • CHMS Chambery
  • University Hospital of Grenoble
  • Calydial
  • E.C.H.O. (Expansion des Centres d'Hémodialyse de l'Ouest)
  • La Conception University Hospital, AP-HM
  • Institut Phocéen de Néphrologie, Clinique Bouchard
  • Uninversity Hospital of Nantes
  • AURA Paris Plaisance
  • European Georges Pompidou Hospital
  • Tenon Hospital, AP-HP
  • Maison Blanche Hospital
  • Rennes Hospital
  • Aub Sante
  • Clinic area
  • Clinique Sainte Anne
  • HIA Sainte-Anne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Alkali

Arm Description

Patients in whom an oral alkalinization whatever the formulation

Outcomes

Primary Outcome Measures

Extracellular compartment M3
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

Natremia (mM)
Evaluation of the impact of oral alkali therapy on natremia (mM)
Urine output (l/d)
Evaluation of the impact of oral alkali therapy on urine output (l/d)
Extracellular compartment M6
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)
Evaluation of the impact of oral alkali therapy on kalemia (mM)
Blood chloride (mM)
Evaluation of the impact of oral alkali therapy on blood chloride (mM)
Bicarbonatemia (mM)
Evaluation of the impact of oral alkali therapy on bicarbonatemia (mM)
Proteinemia (g/l)
Evaluation of the impact of oral alkali therapy on proteinemia (mM)
Albuminemia (g/l)
Evaluation of the impact of oral alkali therapy on albuminemia (mM)
Creatininemia (microM)
Evaluation of the impact of oral alkali therapy on creatininemia (mM)
Natriuresis (mmol/d)
Evaluation of the impact of oral alkali therapy on natriuresis (mmol/d)
Urine chloride (mmol/d)
Evaluation of the impact of oral alkali therapy on urine chloride (mmol/d)
Proteinuria (g/d)
Evaluation of the impact of oral alkali therapy on proteinuria (g/d)
Creatinuria (mmol/d)
Evaluation of the impact of oral alkali therapy on creatinuria (mmol/d)

Full Information

First Posted
January 26, 2017
Last Updated
July 13, 2020
Sponsor
Jean-Philippe Bertocchio
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1. Study Identification

Unique Protocol Identification Number
NCT03035812
Brief Title
Alkalinization by Urologists & Nephrologists
Acronym
AlcalUN
Official Title
Prospective Evaluation of Oral Alkalinization by Urologists and Nephrologists: Evolution of the Extracellular Compartment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
February 21, 2020 (Actual)
Study Completion Date
February 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jean-Philippe Bertocchio

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Acidosis, Nephrolithiasis, Extracellular Alteration, Blood Pressure, Body Weight
Keywords
Bicarbonate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Clinical and biological evaluation before and after an oral alkalinization
Masking
None (Open Label)
Allocation
N/A
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alkali
Arm Type
Experimental
Arm Description
Patients in whom an oral alkalinization whatever the formulation
Intervention Type
Drug
Intervention Name(s)
Alkali
Other Intervention Name(s)
Bicarbonate, Citrate
Intervention Description
Oral intake of alkali therapy whatever the formulation (alkali-based water, powder or pharmaceutics)
Primary Outcome Measure Information:
Title
Extracellular compartment M3
Description
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
Time Frame
At M3 (month 3)
Secondary Outcome Measure Information:
Title
Natremia (mM)
Description
Evaluation of the impact of oral alkali therapy on natremia (mM)
Time Frame
At M3 (month 3)
Title
Urine output (l/d)
Description
Evaluation of the impact of oral alkali therapy on urine output (l/d)
Time Frame
At M3 (month 3)
Title
Extracellular compartment M6
Description
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
Time Frame
At M6 (month 6)
Title
Kalemia (mM)
Description
Evaluation of the impact of oral alkali therapy on kalemia (mM)
Time Frame
At M3 (month 3)
Title
Blood chloride (mM)
Description
Evaluation of the impact of oral alkali therapy on blood chloride (mM)
Time Frame
At M3 (month 3)
Title
Bicarbonatemia (mM)
Description
Evaluation of the impact of oral alkali therapy on bicarbonatemia (mM)
Time Frame
At M3 (month 3)
Title
Proteinemia (g/l)
Description
Evaluation of the impact of oral alkali therapy on proteinemia (mM)
Time Frame
At M3 (month 3)
Title
Albuminemia (g/l)
Description
Evaluation of the impact of oral alkali therapy on albuminemia (mM)
Time Frame
At M3 (month 3)
Title
Creatininemia (microM)
Description
Evaluation of the impact of oral alkali therapy on creatininemia (mM)
Time Frame
At M3 (month 3)
Title
Natriuresis (mmol/d)
Description
Evaluation of the impact of oral alkali therapy on natriuresis (mmol/d)
Time Frame
At M3 (month 3)
Title
Urine chloride (mmol/d)
Description
Evaluation of the impact of oral alkali therapy on urine chloride (mmol/d)
Time Frame
At M3 (month 3)
Title
Proteinuria (g/d)
Description
Evaluation of the impact of oral alkali therapy on proteinuria (g/d)
Time Frame
At M3 (month 3)
Title
Creatinuria (mmol/d)
Description
Evaluation of the impact of oral alkali therapy on creatinuria (mmol/d)
Time Frame
At M3 (month 3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Beaume, MD
Organizational Affiliation
Club des Jeunes Néphrologues
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Pierre Oudot - Bourgoin-Jallieu
City
Bourgoin
ZIP/Postal Code
38300
Country
France
Facility Name
La Cavale Blanche Hospital
City
Brest
ZIP/Postal Code
29600
Country
France
Facility Name
CHMS Chambery
City
Chambéry
Country
France
Facility Name
University Hospital of Grenoble
City
Grenoble
Country
France
Facility Name
Calydial
City
Irigny
Country
France
Facility Name
E.C.H.O. (Expansion des Centres d'Hémodialyse de l'Ouest)
City
Le Mans
ZIP/Postal Code
72016
Country
France
Facility Name
La Conception University Hospital, AP-HM
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Institut Phocéen de Néphrologie, Clinique Bouchard
City
Marseille
Country
France
Facility Name
Uninversity Hospital of Nantes
City
Nantes
Country
France
Facility Name
AURA Paris Plaisance
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
European Georges Pompidou Hospital
City
Paris
ZIP/Postal Code
75908
Country
France
Facility Name
Tenon Hospital, AP-HP
City
Paris
Country
France
Facility Name
Maison Blanche Hospital
City
Reims
Country
France
Facility Name
Rennes Hospital
City
Rennes
Country
France
Facility Name
Aub Sante
City
Saint Malo
ZIP/Postal Code
35400
Country
France
Facility Name
Clinic area
City
Strasbourg
Country
France
Facility Name
Clinique Sainte Anne
City
Strasbourg
Country
France
Facility Name
HIA Sainte-Anne
City
Toulon
ZIP/Postal Code
83000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34564842
Citation
Beaume J, Figueres L, Bobot M, de Laforcade L, Ayari H, Dolley-Hitze T, Gueutin V, Braconnier A, Golbin L, Citarda S, Seret G, Belaid L, Cohen R, Luque Y, Larceneux F, Seervai RNH, Overs C, Bertocchio JP; Club des Jeunes Nephrologues. Sodium Bicarbonate Prescription and Extracellular Volume Increase: Real-world Data Results from the AlcalUN Study. Clin Pharmacol Ther. 2022 Jan;111(1):252-262. doi: 10.1002/cpt.2427. Epub 2021 Oct 11.
Results Reference
derived

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Alkalinization by Urologists & Nephrologists

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