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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Soon Chun Hyang University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Soon Chun Hyang University
ClinicalTrials.gov Identifier:
NCT00760591
First received: September 25, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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
Acute Kidney Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Change of Neutrophil Gelatinase-Associated Lipocalin(NGAL) Following Sodium Phosphate Bowel Preparation(Pilot Study)

Resource links provided by NLM:


Further study details as provided by Soon Chun Hyang University:

Primary Outcome Measures:
  • NGAL [ Time Frame: Baseline, colonoscopy day, post 1day, post 2 day ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Serum, Urine


Estimated Enrollment: 30
Study Start Date: September 2008
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dong Cheol Han MD, Soon Chun Hyang University
ClinicalTrials.gov Identifier: NCT00760591     History of Changes
Other Study ID Numbers: 2008-41
Study First Received: September 25, 2008
Last Updated: September 25, 2008
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014