Acute Kidney FailureNCT00760591
Change of Neutrophil Gelatinase-Associated Lipocalin(NGAL) Following Sodium Phosphate Bowel Preparation(Pilot Study)
An observational study of Acute Kidney Failure, run by Soon Chun Hyang University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Failure
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2008to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 18-65 year old volunteers who want to get colonoscopy
Who may be able to join
None listed.
Who cannot join
- Who takes ACE-inhibitor, ARB
- Has a renal or heart disease
- Has a serum electrolyte disturbance
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Soon Chun Hyang University Hospital
Seoul, 140-743
Soon Hyo Kwon, MD, +8-02-709-9491, ksoonhyo@hosp.sch.ac.kr
Dong Cheol Han, MD
About this 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.
- Conditions
- Acute Kidney Failure
- Keywords
- Acute kidney failure, Colonoscopy, Neutrophil gelatinase-associated lipocalin
- Medical subject headings
- Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
NGAL
Measured: Baseline, colonoscopy day, post 1day, post 2 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soon Chun Hyang University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760591
- Sponsor's protocol ID
- 2008-41
- Status last verified
- Sep 2008
- First submitted
- 25 Sep 2008
- Last updated
- 26 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change of Neutrophil Gelatinase-Associated Lipocalin(NGAL) Following Sodium Phosphate Bowel Preparation(Pilot Study)
- ClinicalTrials.gov ID
- NCT00760591
- Acronym / sponsor ID
- 2008-41
- Conditions
- Acute Kidney Failure
- Keywords
- Acute kidney failure, Colonoscopy, Neutrophil gelatinase-associated lipocalin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Soon Chun Hyang UniversityUniversity, hospital or other
- Study start
- Sep 2008
- First posted
- 26 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 18-65 year old volunteers who want to get colonoscopy
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Who takes ACE-inhibitor, ARB
- Has a renal or heart disease
- Has a serum electrolyte disturbance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
NGAL
Time frame: Baseline, colonoscopy day, post 1day, post 2 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Failure, run by Soon Chun Hyang University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Soon Hyo Kwon, MD (+8-02-709-9491, ksoonhyo@hosp.sch.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NGAL (time frame: Baseline, colonoscopy day, post 1day, post 2 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2008.