Pharmacological Modulation of the Intrarenal Pressure During Endourological Procedures in the Upper Urinary Tract

Kidney Stone Clinical Trial

Official title:

Pharmacological Modulation of the Intrarenal Pressure During Endourological Procedures in the Upper Urinary Tract

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00428428
• Other study ID #: HJ2
• Secondary ID: EudraCT nummer:
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 29, 2007
• Last updated: November 15, 2007
• Start date: February 2007
• Est. completion date: November 2007

Study information

• Verified date: November 2007
• Source: Fredericia Hosptial
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to examine the effect of endoluminally administrated isoproterenol on pelvic pressure increase during flexible ureterorenoscopy in 14 humans. We propose that isoproterenol has potential of reducing intrarenal pressure during ureterorenoscopies. Lower intrarenal pressures may have the advantage of facilitating the procedure and reducing intraoperative complications as bleeding and infections.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Indication for ureterorenoscopy

• Age> 18 years

• Normal blood pressure

Exclusion Criteria:

• Malignant disease in the upper urinary tract

• Heart disease

• Allergy to Isoproterenol

• Use of a-blocking or ß-blocking medicine

• Use of Calcium-antagonists

• Use of NSAIDs the last 48 hours

• Present stone or JJ-stent in the ureter

• Neurologic disease in the bladder

• Pregnancy

• Nursing mothers

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benignant Tumour Mass in the Upper Urinary Tract
• Kidney Calculi
• Kidney Stone
• Nephrolithiasis
• Unexplained Haematuria

Intervention

Drug:
• Isoproterenol
ISO 0.1 microgram/ml, 8 ml/min irrigation compared to saline irrigation

Locations

Country	Name	City	State
Denmark	Dp. of Urology, Fredericia & Kolding Hospitals	Fredericia

Sponsors (1)

Lead Sponsor	Collaborator
Fredericia Hosptial

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pelvic pressure