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

First Received on May 8, 2006. Last Updated on January 29, 2007 History of Changes

Sponsor:	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

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

Drug Information available for: Isoproterenol hydrochloride Isoproterenol sulfate Isoproterenol

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 February 12, 2012