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Retrograde Intrarenal Stone Surgery - A Method of Treating the ESWL Resistant Kidney Stone

This study is ongoing, but not recruiting participants.

Sponsored by: Fredericia Hosptial
Information provided by: Fredericia Hosptial
ClinicalTrials.gov Identifier: NCT00323843
  Purpose

Is it possible to decrease the intrarenal pressure in the kidney during endoscopic management of kidney stone by topical administration of drugs? In order to secure fewer complications in ureteroscopic operations the pharmacological agent isoproterenol is tested on pigs and human to determine its potential of lowering intrarenal pressure.


Condition Intervention Phase
Kidney Stone
Ureteroscopy
Drug: Isoproterenol
Phase II

ChemIDplus related topics:   Isoproterenol    Isoproterenol hydrochloride    Isoproterenol sulfate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   RIRS - A Method of Treating the ESWL Resistant Kidney Stone

Further study details as provided by Fredericia Hosptial:

Primary Outcome Measures:
  • Renal pelvic pressure

Secondary Outcome Measures:
  • Blood pressure
  • Pulse

Estimated Enrollment:   10
Study Start Date:   June 2006
Estimated Study Completion Date:   February 2007

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

Criteria

Inclusion Criteria:

  • Indication for RIRS procedure
  • Age > 18 years
  • Normotensive
  • Capable of understanding information given

Exclusion Criteria:

  • Previous myocardiac infarct
  • Daily use of alpha- og beta- blocking medicine og calcium antagonists
  • Use of NSAID the last 2 days
  • Stone in the ureter
  • Declared
  • Known malignant disease in urinary tract
  • Bladder disease
  • Nephrostomies inserted
  • JJ-catheters inserted
  • Prisoners
  • Pregnant
  • Nursing mothers
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00323843

Locations
Denmark, Vejle Council
Dpt. of Urology    
      Fredericia, Vejle Council, Denmark, 7000

Sponsors and Collaborators
Fredericia Hosptial

Investigators
Principal Investigator:     Helene U Jung     Fredericia Hospital, Dpt. of Urology    
  More Information

Study ID Numbers:   2005-005972-34
First Received:   May 8, 2006
Last Updated:   January 29, 2007
ClinicalTrials.gov Identifier:   NCT00323843
Health Authority:   Denmark: Danish Medicines Agency;   Denmark: Ethics Committee

Keywords provided by Fredericia Hosptial:
Kidney stone  
ureteropyeloscopy  
renal pelvic pressure  

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Urinary Calculi
Urologic Diseases
Urolithiasis
Kidney Diseases
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
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on September 05, 2008




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