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

Urolithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03343743
• Other study ID #: 6118/13
• Status: Completed
• Phase: N/A
• First received: November 10, 2017
• Last updated: November 10, 2017
• Start date: June 2013
• Est. completion date: June 2014

Study information

• Verified date: November 2017
• Source: Policlinico Universitario Agostino Gemelli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urolithiasis

Intervention

Other:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Policlinico Universitario Agostino Gemelli

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in renal papillary density	Renal papillary density measured with unenhanced CT scan	At baseline and after 12 months