Chronic Kidney DiseaseNCT02233010
Usefulness of Neutrophil Gelatinase-associated Lipocalin(NGAL) to Confirm Acute Kidney Function Decrease of the Patients Who Had Non-cardiac Surgery
An observational study of Chronic Kidney Disease, run by Inje University.
Trial summary
Although post-op renal function decrease is determined by serum creatinine, serum creatinine has disadvantages that it increases a long time after renal function decrease and it has various increasing time based on the level of renal function. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- The level of NGAL after pre op,post op 4hr, post op 12hr
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Aug 2014
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 43 patients who had non-cardiac surgery in Seoul Paik Hospital.
Who may be able to join
- 43 patients who had non-cardiac surgery in Seoul Paik Hospital.
Who cannot join
- have viral hepatitis and Aspartate aminotransferase, Alanine aminotransferase > 2 time of normal level
- severe lung disease
- severe heart failure ( Ejection Fraction < 40% )
- pregnancy
About this study
Although post-op renal function decrease is determined by serum creatinine, serum creatinine has disadvantages that it increases a long time after renal function decrease and it has various increasing time based on the level of renal function. Neutrophil Gelatinase-associated Lipocalin (NGAL's) usefulness as an evidence for acute kidney damage occurring from post-op cardiac surgery, being critical patients and contrast medium use is already proven.
But NGAL's usefulness for renal function after non-cardiac surgery is not proven and especially, NGAL's usefulness for renal injury after non-cardiac surgery in chronic renal disease patients is not proven.Therefore, the investigators will study about renal function decrease after non-cardiac surgery with NGAL and serum creatinine.
- Conditions
- Chronic Kidney Disease
- Being tested
- The level of NGAL after pre op,post op 4hr, post op 12hr
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The level of NGAL after pre op,post op 4hr, post op 12hrOther
| Study group | Role | What they receive |
|---|---|---|
| kidney function normal group | kidney function normal group : defined by the normal level of NGAL after post operation 4hrs Receives: Other: The level of NGAL after pre op,post op 4hr, post op 12hr | |
| kidney function decreased group | kidney function decreased group : defined by the increased level of NGAL after post operation 4hrs Receives: Other: The level of NGAL after pre op,post op 4hr, post op 12hr |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum NGAL level
Measured: up to post operation 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hoseok Koo, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233010
- Sponsor's protocol ID
- postOPNGAL01
- Status last verified
- Sep 2014
- First submitted
- 1 Sep 2014
- Last updated
- 8 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Neutrophil Gelatinase-associated Lipocalin(NGAL) to Confirm Acute Kidney Function Decrease of the Patients Who Had Non-cardiac Surgery
- ClinicalTrials.gov ID
- NCT02233010
- Acronym / sponsor ID
- postOPNGAL01
- Conditions
- Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Aug 2014 (actual)
- First posted
- 8 Sep 2014 (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.
Although post-op renal function decrease is determined by serum creatinine, serum creatinine has disadvantages that it increases a long time after renal function decrease and it has various increasing time based on the level of renal function. Neutrophil Gelatinase-associated Lipocalin (NGAL's) usefulness as an evidence for acute kidney damage occurring from post-op cardiac surgery, being critical patients and contrast medium use is already proven.
But NGAL's usefulness for renal function after non-cardiac surgery is not proven and especially, NGAL's usefulness for renal injury after non-cardiac surgery in chronic renal disease patients is not proven.Therefore, the investigators will study about renal function decrease after non-cardiac surgery with NGAL and serum creatinine.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| kidney function normal group | – | Other: The level of NGAL after pre op,post op 4hr, post op 12hrkidney function normal group : defined by the normal level of NGAL after post operation 4hrs |
| kidney function decreased group | – | Other: The level of NGAL after pre op,post op 4hr, post op 12hrkidney function decreased group : defined by the increased level of NGAL after post operation 4hrs |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 43 patients who had non-cardiac surgery in Seoul Paik Hospital.
Key inclusion criteria (1 listed)
- 43 patients who had non-cardiac surgery in Seoul Paik Hospital.
Key exclusion criteria (4 listed)
- have viral hepatitis and Aspartate aminotransferase, Alanine aminotransferase > 2 time of normal level
- severe lung disease
- severe heart failure ( Ejection Fraction < 40% )
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The level of NGAL after pre op,post op 4hr, post op 12hr | Other | kidney function decreased group, kidney function normal group |
Primary outcome
serum NGAL level
Time frame: up to post operation 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by Inje University.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 8 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum NGAL level (time frame: up to post operation 12 hours). 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 8 Sep 2014.