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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Fredericia Hosptial.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Fredericia Hosptial
ClinicalTrials.gov Identifier:
NCT00323843
First received: May 8, 2006
Last updated: January 29, 2007
Last verified: January 2007
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: RIRS - A Method of Treating the ESWL Resistant Kidney Stone

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:
  • 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
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

No publications provided

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

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

Additional relevant MeSH terms:
Calculi
Kidney Calculi
Nephrolithiasis
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
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 23, 2013