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Urinary Biomarkers as Predictors on Renal Function in Congenital Hydronephrosis

Sponsor
University of Aarhus (Other)
Overall Status
Completed
CT.gov ID
NCT00568724
Collaborator
Aarhus University Hospital (Other)
45
Enrollment
1
Location
50
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to detect new urinary biomarkers that can be used as predictors on renal function in congenital hydronephrosis caused by unilateral ureteral obstruction (UUO) and to elucidate the pathophysiology of UUO.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    45 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Urinary Biomarkers as Predictors on Renal Function in Congenital Hydronephrosis
    Study Start Date :
    Nov 1, 2007
    Actual Primary Completion Date :
    Jan 1, 2012
    Actual Study Completion Date :
    Jan 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Children referred to surgical treatment of congenital hydronephrosis
    2

    15 age- and sex-matched controls
    Children with healthy pelvic tissue

    Children referred to nephrectomy due to nephrotic syndrome
    Adults with healthy pelvic tissue

    Adults referred to nephrectomy due to another cause than hydronephrosis

    Outcome Measures

    Primary Outcome Measures

    1. Urinary cytokines [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Months to 15 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Children referred to surgical treatment of congenital hydronephrosis caused by ureteral obstruction.

    • Declining function of the hydronephrotic kidney more than 5 %, and to less than 40 % of the total renal function OR ipsilateral flank pain.

    Exclusion Criteria:

    • Bilateral hydronephrosis

    • Previous operation in the urinary system except operation for phimosis and other deformations of the external genital organs.

    • Deformations in the lower part of the ureter, bladder and urethra. Urinary stones. Reflux. Urinary tract infections < 6 months.

    • Neurogenic bladder dysfunction.

    • GFR < 40 % standardized to age.

    • Non-compliance. Linguistic difficulties.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institute of Clinical Medicine, University of Aarhus Aarhus Denmark 8200

    Sponsors and Collaborators

    • University of Aarhus
    • Aarhus University Hospital

    Investigators

    • Principal Investigator: Troels M Jørgensen, Professor, MD, Department of Urology, Aarhus University Hospital Skejby

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Aarhus
    ClinicalTrials.gov Identifier:
    NCT00568724
    Other Study ID Numbers:
    • MGM-01
    First Posted:
    Dec 6, 2007
    Last Update Posted:
    Sep 14, 2012
    Last Verified:
    Sep 1, 2012
    Keywords provided by University of Aarhus
    Hydronephrosis
    Ureteral obstruction
    Additional relevant MeSH terms:
    Hydronephrosis
    Ureteral Obstruction

    Study Results

    No Results Posted as of Sep 14, 2012