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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Kidney Failure

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 140-743
    • Recruiting
    • Soon Chun Hyang University Hospital
    • Contact: Soon Hyo Kwon, MD; Phone Number: +8-02-709-9491; Email: ksoonhyo@hosp.sch.ac.kr
    • Principal Investigator: Dong Cheol Han, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

18-65 year old volunteers who want to get colonoscopy

Description

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
NGAL	Baseline, colonoscopy day, post 1day, post 2 day

Collaborators and Investigators

• Sponsor: Soon Chun Hyang University

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: September 25, 2008
• First Submitted That Met QC Criteria: September 25, 2008
• First Posted (Estimate): September 26, 2008

Study Record Updates

• Last Update Posted (Estimate): September 26, 2008
• Last Update Submitted That Met QC Criteria: September 25, 2008
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Keywords: Colonoscopy; Acute kidney failure; Neutrophil gelatinase-associated lipocalin
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: 2008-41

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No