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

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

ChemIDplus related topics:

Sodium chloride Isoproterenol Isoproterenol hydrochloride Isoproterenol sulfate

U.S. FDA Resources

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

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

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

Keywords provided by Fredericia Hosptial:

kidney stone

ureteroscopy

Study placed in the following topic categories:

Pathological Conditions, Anatomical

Urinary Calculi

Urologic Diseases

Hematuria

Urination Disorders

Urolithiasis

Kidney Diseases

Hemorrhage

Calculi

Nephrolithiasis

Isoproterenol

Kidney Calculi

Additional relevant MeSH terms:

Respiratory System Agents

Neurotransmitter Agents

Adrenergic beta-Agonists

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

Sympathomimetics

Cardiotonic Agents

Physiological Effects of Drugs

Anti-Asthmatic Agents

Cardiovascular Agents

Protective Agents

Adrenergic Agonists

Pharmacologic Actions

Pathologic Processes

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Bronchodilator Agents

ClinicalTrials.gov processed this record on October 03, 2008

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