Acute Kidney InjuryNCT02743273
Identification of Prognostic Urinary Biomarker for Acute Kidney Injury in Preterm Infants by Proteomics
An observational study of Acute Kidney Injury, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Clinical definitions of acute kidney injury (AKI) have been based on an increase in serum creatinine and a decrease in urine output. However, applying this definition to neonates remains challenging because of the normal renal physiologic features that serum creatinine levels are expected to increase in the first days… Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2015to Nov 2017
- How long will I take part?
- 3 Months
- 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 Up to 3 months
- All sexes
- No healthy volunteers
- Child
Study population: 1. Preterm infants with gestational age<32 weeks or birth weight<1,500 g who enrolled our institutional prospective cohort study for biorepository. 2. Preterm infants with gestational age<32 weeks or birth weight< 1,500 g who need ibuprofen treatment for closing patent ductus arteriosus.
Who may be able to join
- Preterm infants less than 32 weeks gestational age or birth weight less than 1,500 g admitted to the neonatal intensive care unit at Seoul National University Children's hospital
Who cannot join
- Congenital heart disease
- Known major congenital anomalies of the kidney and urinary tract
- Other genetic syndromes or medical conditions that preclude enrollment per judgement of the attending neonatologist
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Children's Hospital
Seoul, 110-744
About this study
Clinical definitions of acute kidney injury (AKI) have been based on an increase in serum creatinine and a decrease in urine output. However, applying this definition to neonates remains challenging because of the normal renal physiologic features that serum creatinine levels are expected to increase in the first days after birth, and impaired sodium reabsorption and concentrating ability.
Because of several limitations of early detection of AKI, investigators are focused on identifying biomarkers that predict AKI before an increase serum creatinine level.
Investigators will collect urine from preterm infants before and after administrating ibuprofen for closing patent ductus arteriosus. To identify novel biomarkers, investigators will analyze urine by proteomics. To verify those biomarkers, investigators will use initial urine on the first day of life from preterm infants who diagnosed AKI within 7 days after birth without any risk factors for AKI and enrolled institutional bio-repository.
- Conditions
- Acute Kidney Injury
- Medical subject headings
- Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
change the level of novel urinary biomarkers after ibuprofen administration
Measured: change from 1 day before ibuprofen administration to 1 day after ibuprofen administration
Secondary outcomes (1)
The level of novel urinary biomarkers in initial urine
Measured: within 24 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startOct 2015
- Primary completionAug 2016
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han-Suk Kim, Seoul National University Hospital
- Investigators
- Han-Suk Kim, MD, PhD., Principal investigator, Seoul National University Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02743273
- Sponsor's protocol ID
- 1507-028-686
- Status last verified
- Jul 2018
- First submitted
- 9 Dec 2015
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Prognostic Urinary Biomarker for Acute Kidney Injury in Preterm Infants by Proteomics
- ClinicalTrials.gov ID
- NCT02743273
- Acronym / sponsor ID
- 1507-028-686
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 19 Apr 2016 (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.
Clinical definitions of acute kidney injury (AKI) have been based on an increase in serum creatinine and a decrease in urine output. However, applying this definition to neonates remains challenging because of the normal renal physiologic features that serum creatinine levels are expected to increase in the first days after birth, and impaired sodium reabsorption and concentrating ability.
Because of several limitations of early detection of AKI, investigators are focused on identifying biomarkers that predict AKI before an increase serum creatinine level.
Investigators will collect urine from preterm infants before and after administrating ibuprofen for closing patent ductus arteriosus. To identify novel biomarkers, investigators will analyze urine by proteomics. To verify those biomarkers, investigators will use initial urine on the first day of life from preterm infants who diagnosed AKI within 7 days after birth without any risk factors for AKI and enrolled institutional bio-repository.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 1. Preterm infants with gestational age<32 weeks or birth weight<1,500 g who enrolled our institutional prospective cohort study for biorepository. 2. Preterm infants with gestational age<32 weeks or birth weight< 1,500 g who need ibuprofen treatment for closing patent ductus arteriosus.
Key inclusion criteria (1 listed)
- Preterm infants less than 32 weeks gestational age or birth weight less than 1,500 g admitted to the neonatal intensive care unit at Seoul National University Children's hospital
Key exclusion criteria (3 listed)
- Congenital heart disease
- Known major congenital anomalies of the kidney and urinary tract
- Other genetic syndromes or medical conditions that preclude enrollment per judgement of the attending neonatologist
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
change the level of novel urinary biomarkers after ibuprofen administration
Time frame: change from 1 day before ibuprofen administration to 1 day after ibuprofen administration
1 secondary outcome
The level of novel urinary biomarkers in initial urine
Time frame: within 24 hours after birth
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 20 Jul 2018.
- Individual participant dataSharing planned: Yes
Related trials for Acute Kidney Injury
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Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
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Acute Kidney Injury and Ultra-endurance Running
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Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
Han-Suk Kim, MD, PhD. principal investigator
Seoul National University Children's Hospital
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 Injury, run by Seoul National University Hospital 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 1 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: finished, as of the sponsor's last update on 20 Jul 2018. 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?
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?
change the level of novel urinary biomarkers after ibuprofen administration (time frame: change from 1 day before ibuprofen administration to 1 day after ibuprofen administration). 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 20 Jul 2018.