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

This study has been completed.

First Received: January 29, 2007 Last Updated: November 15, 2007 History of Changes

Sponsor:	Fredericia Hosptial
Information provided by:	Fredericia Hosptial
ClinicalTrials.gov Identifier:	NCT00428428

Purpose

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.

Condition	Intervention	Phase
Kidney Stone Unexplained Haematuria Benignant Tumour Mass in the Upper Urinary Tract	Drug: Isoproterenol	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Pharmacological Modulation of the Intrarenal Pressure During Endourological Procedures in the Upper Urinary Tract

Resource links provided by NLM:

Drug Information available for: Isoproterenol hydrochloride Isoproterenol sulfate Isoproterenol

U.S. FDA Resources

Further study details as provided by Fredericia Hosptial:

Primary Outcome Measures:

pelvic pressure

Enrollment:	12
Study Start Date:	February 2007
Study Completion Date:	November 2007

Arms	Assigned Interventions
1: Placebo Comparator Saline irrigation	Drug: Isoproterenol ISO 0.1 microgram/ml, 8 ml/min irrigation compared to saline irrigation
2: Active Comparator ISO irrigation	Drug: Isoproterenol ISO 0.1 microgram/ml, 8 ml/min irrigation compared to saline irrigation

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428428

Locations

Denmark
Dp. of Urology, Fredericia & Kolding Hospitals
Fredericia, Denmark, 7000

Sponsors and Collaborators

Fredericia Hosptial

Investigators

Study Director:

Palle JS Osther, PhD, MD

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

More Information

No publications provided

Study ID Numbers:	HJ2, EudraCT nummer: 2006-005756-32
Study First Received:	January 29, 2007
Last Updated:	November 15, 2007
ClinicalTrials.gov Identifier:	NCT00428428 History of Changes
Health Authority:	Denmark: Danish Medicines Agency; Denmark: Ethics Committee

Keywords provided by Fredericia Hosptial:

kidney stone
ureteroscopy

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Urinary Calculi
Respiratory System Agents
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Urolithiasis
Physiological Effects of Drugs
Calculi
Hemorrhage
Adrenergic Agonists
Pathologic Processes
Urologic Diseases
Hematuria

Therapeutic Uses
Kidney Diseases
Kidney Calculi
Adrenergic beta-Agonists
Sympathomimetics
Urination Disorders
Anti-Asthmatic Agents
Cardiovascular Agents
Protective Agents
Isoproterenol
Pharmacologic Actions
Autonomic Agents
Peripheral Nervous System Agents
Nephrolithiasis
Bronchodilator Agents

ClinicalTrials.gov processed this record on November 27, 2009