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Change of Neutrophil Gelatinase-Associated Lipocalin(NGAL) Following Sodium Phosphate Bowel Preparation(Pilot Study)

Sponsor
Soon Chun Hyang University (Other)
Overall Status
Unknown status
CT.gov ID
NCT00760591
Collaborator
(none)
30
Enrollment
1
Location

Study Details

Study Description

Brief Summary

Oral phosphate purgative is the preferred bowel regimen on the basis of better tolerability, cost effectiveness, and efficacy. There are also numerous reports of patients with even previously normal renal function developing acute and chronic kidney disease after use of oral phosphate purgative. Several uncontrolled case reports and case series suggest a potential link between oral phosphate and acute kidney injury and/or chronic kidney disease1. Its use is contraindicated in patients with preexisting renal disease because of the risk for developing acute renal failure, so called acute phosphate nephropathy, or electrolyte disturbance. Since most of the outpatients who are going to undergo a colonoscopy are exposed to this agent, it is important to detect or prevent vulnerable patients. We would seek a sensitive and rapid diagnosis method of acute kidney injury following sodium phosphate bowel preparation. Within a few hours, NGAL mRNA is highly upregulated after kidney injury, such as renal ischemia-reperfusion and cisplatin nephropathy, NGAL induction precedes the elevation of classical markers for kidney damage such as serum creatinine. The investigators will investigate the change of NGAL following sodium phosphate bowel preparation.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Change of Neutrophil Gelatinase-Associated Lipocalin(NGAL) Following Sodium Phosphate Bowel Preparation(Pilot Study)
    Study Start Date :
    Sep 1, 2008

    Outcome Measures

    Primary Outcome Measures

    1. NGAL [Baseline, colonoscopy day, post 1day, post 2 day]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Exclusion Criteria:

    • Who takes ACE-inhibitor, ARB

    • Has a renal or heart disease

    • Has a serum electrolyte disturbance

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Soon Chun Hyang University Hospital Seoul Korea, Republic of 140-743

    Sponsors and Collaborators

    • Soon Chun Hyang University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00760591
    Other Study ID Numbers:
    • 2008-41
    First Posted:
    Sep 26, 2008
    Last Update Posted:
    Sep 26, 2008
    Last Verified:
    Sep 1, 2008
    Keywords provided by , ,
    Acute kidney failure
    Colonoscopy
    Neutrophil gelatinase-associated lipocalin
    Additional relevant MeSH terms:
    Renal Insufficiency
    Acute Kidney Injury

    Study Results

    No Results Posted as of Sep 26, 2008