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

This study has been completed.
Sponsor:
Information provided by:
Fredericia Hosptial
ClinicalTrials.gov Identifier:
NCT00428428
First received: January 29, 2007
Last updated: November 15, 2007
Last verified: November 2007

January 29, 2007
November 15, 2007
February 2007
Not Provided
pelvic pressure
Same as current
Complete list of historical versions of study NCT00428428 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Pharmacological Modulation of the Intrarenal Pressure During Endourological Procedures in the Upper Urinary Tract
Pharmacological Modulation of the Intrarenal Pressure During Endourological Procedures in the Upper Urinary Tract

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
  • Kidney Stone
  • Unexplained Haematuria
  • Benignant Tumour Mass in the Upper Urinary Tract
Drug: Isoproterenol
ISO 0.1 microgram/ml, 8 ml/min irrigation compared to saline irrigation
  • Placebo Comparator: 1
    Saline irrigation
    Intervention: Drug: Isoproterenol
  • Active Comparator: 2
    ISO irrigation
    Intervention: Drug: Isoproterenol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
November 2007
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00428428
HJ2, EudraCT nummer: 2006-005756-32
Yes
Not Provided
Fredericia Hosptial
Not Provided
Study Director: Palle JS Osther, PhD, MD Dp. of Urology, Fredericia & Kolding Hospitals, Fredericia, denmark
Fredericia Hosptial
November 2007

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