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

NCT ID: NCT03343743

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Urolithiasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hydration

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

Group Type OTHER

Oligomineral water

Intervention Type OTHER

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

Interventions

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Oligomineral water

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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type DERIVED
PMID: 30419887 (View on PubMed)

Other Identifiers

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6118/13

Identifier Type: -

Identifier Source: org_study_id