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Pharmacological Modulation of the Intrarenal Pressure During Endourological Procedures in the Upper Urinary Tract

NCT ID: NCT00428428

Last Updated: 2007-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-11-30

Brief Summary

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The purpose of the study is to examine the effect of endoluminally administrated isoproterenol on pelvic pressure increase during flexible ureterorenoscopy in 14 humans. We propose that isoproterenol has potential of reducing intrarenal pressure during ureterorenoscopies. Lower intrarenal pressures may have the advantage of facilitating the procedure and reducing intraoperative complications as bleeding and infections.

Detailed Description

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Conditions

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Kidney Stone Unexplained Haematuria Benignant Tumour Mass in the Upper Urinary Tract

Keywords

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kidney stone ureteroscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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1

Saline irrigation

Group Type PLACEBO_COMPARATOR

Isoproterenol

Intervention Type DRUG

ISO 0.1 microgram/ml, 8 ml/min irrigation compared to saline irrigation

2

ISO irrigation

Group Type ACTIVE_COMPARATOR

Isoproterenol

Intervention Type DRUG

ISO 0.1 microgram/ml, 8 ml/min irrigation compared to saline irrigation

Interventions

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Isoproterenol

ISO 0.1 microgram/ml, 8 ml/min irrigation compared to saline irrigation

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Indication for ureterorenoscopy
* Age\> 18 years
* Normal blood pressure

Exclusion Criteria

* Malignant disease in the upper urinary tract
* Heart disease
* Allergy to Isoproterenol
* Use of α-blocking or β-blocking medicine
* Use of Calcium-antagonists
* Use of NSAIDs the last 48 hours
* Present stone or JJ-stent in the ureter
* Neurologic disease in the bladder
* Pregnancy
* Nursing mothers
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fredericia Hosptial

OTHER

Sponsor Role lead

Principal Investigators

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Palle JS Osther, PhD, MD

Role: STUDY_DIRECTOR

Dp. of Urology, Fredericia & Kolding Hospitals, Fredericia, denmark

Locations

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Dp. of Urology, Fredericia & Kolding Hospitals

Fredericia, Fredericia, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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EudraCT nummer: 2006-005756-32

Identifier Type: -

Identifier Source: secondary_id

HJ2

Identifier Type: -

Identifier Source: org_study_id