NCT00428428

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2007

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

November 16, 2007

Status Verified

November 1, 2007

First QC Date

January 29, 2007

Last Update Submit

November 15, 2007

Conditions

Kidney StoneUnexplained HaematuriaBenignant Tumour Mass in the Upper Urinary Tract

Keywords

kidney stoneureteroscopy

Outcome Measures

Primary Outcomes (1)

  • pelvic pressure

Study Arms (2)

1

PLACEBO COMPARATOR

Saline irrigation

Drug: Isoproterenol

2

ACTIVE COMPARATOR

ISO irrigation

Drug: Isoproterenol

Interventions

IsoproterenolDRUG

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

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dp. of Urology, Fredericia & Kolding Hospitals

Fredericia, Fredericia, 7000, Denmark

Location

MeSH Terms

Conditions

Kidney Calculi

Interventions

Isoproterenol

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Palle JS Osther, PhD, MD

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 29, 2007

First Posted

January 30, 2007

Study Start

February 1, 2007

Study Completion

November 1, 2007

Last Updated

November 16, 2007

Record last verified: 2007-11

Locations

DK(1)