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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00428428
First Posted: January 30, 2007
Last Update Posted: November 16, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Fredericia Hosptial
  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
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, 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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00428428     History of Changes
Other Study ID Numbers: HJ2
EudraCT nummer: 2006-005756-32
First Submitted: January 29, 2007
First Posted: January 30, 2007
Last Update Posted: November 16, 2007
Last Verified: November 2007

Keywords provided by Fredericia Hosptial:
kidney stone
ureteroscopy

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


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