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

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ClinicalTrials.gov Identifier: NCT00323843
Recruitment Status : Unknown
Verified January 2007 by Fredericia Hosptial.
Recruitment status was:  Active, not recruiting
First Posted : May 10, 2006
Last Update Posted : January 30, 2007
Sponsor:
Information provided by:
Fredericia Hosptial

Brief Summary:
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 or disease Intervention/treatment Phase
Kidney Stone Ureteroscopy Drug: Isoproterenol Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RIRS - A Method of Treating the ESWL Resistant Kidney Stone
Study Start Date : June 2006
Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones
U.S. FDA Resources




Primary Outcome Measures :
  1. Renal pelvic pressure

Secondary Outcome Measures :
  1. Blood pressure
  2. Pulse


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 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

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): NCT00323843


Locations
Denmark
Dpt. of Urology
Fredericia, Vejle Council, Denmark, 7000
Sponsors and Collaborators
Fredericia Hosptial
Investigators
Principal Investigator: Helene U Jung Fredericia Hospital, Dpt. of Urology

ClinicalTrials.gov Identifier: NCT00323843     History of Changes
Other Study ID Numbers: 2005-005972-34
First Posted: May 10, 2006    Key Record Dates
Last Update Posted: January 30, 2007
Last Verified: January 2007

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

Additional relevant MeSH terms:
Kidney Calculi
Nephrolithiasis
Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
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