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

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ClinicalTrials.gov Identifier: NCT00760591
Recruitment Status : Unknown
Verified September 2008 by Soon Chun Hyang University.
Recruitment status was:  Recruiting
First Posted : September 26, 2008
Last Update Posted : September 26, 2008
Sponsor:
Information provided by:

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
Acute Kidney Failure

Study Design

Study Type : Observational
Estimated 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 : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. NGAL [ Time Frame: Baseline, colonoscopy day, post 1day, post 2 day ]

Biospecimen Retention:   None Retained
Serum, Urine

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
18-65 year old volunteers who want to get colonoscopy
Criteria

Exclusion Criteria:

  • Who takes ACE-inhibitor, ARB
  • Has a renal or heart disease
  • Has a serum electrolyte disturbance
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00760591


Contacts
Contact: Soon Hyo Kwon, MD +8-02-709-9491 ksoonhyo@hosp.sch.ac.kr

Locations
Korea, Republic of
Soon Chun Hyang University Hospital Recruiting
Seoul, Korea, Republic of, 140-743
Contact: Soon Hyo Kwon, MD    +8-02-709-9491    ksoonhyo@hosp.sch.ac.kr   
Principal Investigator: Dong Cheol Han, MD         
Sponsors and Collaborators
Soon Chun Hyang University
More Information

Responsible Party: Dong Cheol Han MD, Soon Chun Hyang University
ClinicalTrials.gov Identifier: NCT00760591     History of Changes
Other Study ID Numbers: 2008-41
First Posted: September 26, 2008    Key Record Dates
Last Update Posted: September 26, 2008
Last Verified: September 2008

Keywords provided by Soon Chun Hyang University:
Acute kidney failure
Colonoscopy
Neutrophil gelatinase-associated lipocalin

Additional relevant MeSH terms:
Renal Insufficiency
Acute Kidney Injury
Kidney Diseases
Urologic Diseases