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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
History of Changes
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacological Modulation of the Intrarenal Pressure During Endourological Procedures in the Upper Urinary Tract

Resource links provided by NLM:

MedlinePlus related topics: Kidney Stones
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
Placebo Comparator: 1
Saline irrigation
 Drug: Isoproterenol
ISO 0.1 microgram/ml, 8 ml/min irrigation compared to saline irrigation
Active Comparator: 2
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

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

Keywords provided by Fredericia Hosptial:
kidney stone
ureteroscopy

Additional relevant MeSH terms:
Hematuria
Kidney Calculi
Nephrolithiasis
Urination Disorders
Urologic Diseases
Hemorrhage
Pathologic Processes
Kidney Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical
Isoproterenol
Adrenergic beta-Agonists
Adrenergic Agonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Cardiotonic Agents
Cardiovascular Agents
Sympathomimetics
Protective Agents

ClinicalTrials.gov processed this record on May 16, 2013