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

Tracking Information

First Received Date ^ICMJE

January 29, 2007

Last Updated Date

November 15, 2007

Start Date ^ICMJE

February 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

pelvic pressure

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00428428 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study

Condition ^ICMJE

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

Intervention ^ICMJE

Drug: Isoproterenol

Study Arms / Comparison Groups

Placebo Comparator: Saline irrigation
Active Comparator: ISO irrigation

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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 α-blocking or β-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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00428428

Responsible Party

Study ID Numbers ^ICMJE

HJ2, EudraCT nummer: 2006-005756-32

Study Sponsor ^ICMJE

Fredericia Hosptial

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Palle JS Osther, PhD, MD

Dp. of Urology, Fredericia & Kolding Hospitals, Fredericia, denmark

Information Provided By

Fredericia Hosptial

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP