search
Back to results

Changes in Renal Papillary Density After Hydration Therapy in Calcium Stone Formers

Primary Purpose

Urolithiasis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oligomineral water
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urolithiasis

Eligibility Criteria

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

Inclusion Criteria:

  • Patients undergoing endourological procedures for renal stones
  • Recurrent stone disease
  • Calcium oxalate stones (>50% of the stone made of calcium oxalate)

Exclusion Criteria:

  • Systemic conditions causing stones (hyperparathyroidism, intestinal malabsorption, renal tubular acidosis)
  • Non-calcium oxalate stones

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Hydration

    Arm Description

    Patients were instructed to drink at least 2 L/day of a hypotonic, oligomineral water low in sodium and minerals (fixed residue at 180°C <200 mg/L) for at least 12 months

    Outcomes

    Primary Outcome Measures

    Changes in renal papillary density
    Renal papillary density measured with unenhanced CT scan

    Secondary Outcome Measures

    Full Information

    First Posted
    November 10, 2017
    Last Updated
    November 10, 2017
    Sponsor
    Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03343743
    Brief Title
    Changes in Renal Papillary Density After Hydration Therapy in Calcium Stone Formers
    Official Title
    Changes in Renal Papillary Density After Hydration Therapy in Calcium Stone Formers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2013 (Actual)
    Primary Completion Date
    June 2014 (Actual)
    Study Completion Date
    June 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    4. Oversight

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

    5. Study Description

    Brief Summary
    Patients with recurrent calcium oxalate stones undergoing endourological procedures for renal stones at our institution from June 2013 to June 2014 were considered eligible for enrolment. Enrolled patients underwent a baseline unenhanced CT scan before the urological procedure; after endoscopic removal of their stones, the patients were instructed to drink at least 2 L/day of a hypotonic, oligomineral water low in sodium and minerals (fixed residue at 180°C <200 mg/L) for at least 12 months. Finally, the patients underwent a follow-up unenhanced CT scan during hydration regimen.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urolithiasis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hydration
    Arm Type
    Other
    Arm Description
    Patients were instructed to drink at least 2 L/day of a hypotonic, oligomineral water low in sodium and minerals (fixed residue at 180°C <200 mg/L) for at least 12 months
    Intervention Type
    Other
    Intervention Name(s)
    Oligomineral water
    Intervention Description
    Patients were instructed to drink at least 2 L/day of a hypotonic, oligomineral water low in sodium and minerals (fixed residue at 180°C <200 mg/L) for at least 12 months
    Primary Outcome Measure Information:
    Title
    Changes in renal papillary density
    Description
    Renal papillary density measured with unenhanced CT scan
    Time Frame
    At baseline and after 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients undergoing endourological procedures for renal stones Recurrent stone disease Calcium oxalate stones (>50% of the stone made of calcium oxalate) Exclusion Criteria: Systemic conditions causing stones (hyperparathyroidism, intestinal malabsorption, renal tubular acidosis) Non-calcium oxalate stones

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30419887
    Citation
    Ferraro PM, Vittori M, Macis G, D'Addessi A, Lombardi G, Palmisano C, Gervasoni J, Primiano A, Bassi PF, Gambaro G. Changes in renal papillary density after hydration therapy in calcium stone formers. BMC Urol. 2018 Nov 12;18(1):101. doi: 10.1186/s12894-018-0415-7.
    Results Reference
    derived

    Learn more about this trial

    Changes in Renal Papillary Density After Hydration Therapy in Calcium Stone Formers

    We'll reach out to this number within 24 hrs