NCT00323843UnknownPhase 2
RIRS - A Method of Treating the ESWL Resistant Kidney Stone
Fredericia Hosptial2 sites in 1 country10 target enrollmentStarted: June 1, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Renal pelvic pressure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Known malignant disease in urinary tract
- •Bladder disease
- •Nephrostomies inserted
- •JJ-catheters inserted
- •Prisoners
- •Nursing mothers
Outcomes
Primary Outcomes
Renal pelvic pressure
Secondary Outcomes
- Blood pressure
- Pulse
Investigators
Study Sites (2)
Loading locations...
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