Acute Kidney InjuryNCT03263325
Evaluation of UDP-glucose as a Urinary Biomarker for Early Detection of Cardiac Surgery-associated Pediatric Acute Kidney Injury
An observational study of Acute Kidney Injury, run by Boston Children's Hospital at 1 site in United States.
Trial summary
Acute kidney injury (AKI) is common in children after cardiac surgery with a reported incidence of 20-40%. Pediatric AKI has been found to be associated with important short and long-term adverse outcomes. Read more about this study
- Who is it for?
- Ages Up to 8 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Discarded urine sample
- How many people
- 305 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2017to 1 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 8 years
- All sexes
- No healthy volunteers
- Child
Study population: Children ≤ 8 years of age having cardiac surgery with cardiopulmonary bypass
Who may be able to join
- less than or equal to 8 years of age
- scheduled for cardiac surgery
Who cannot join
- severe pre-existing renal insufficiency
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Acute kidney injury (AKI) is common in children after cardiac surgery with a reported incidence of 20-40%. Pediatric AKI has been found to be associated with important short and long-term adverse outcomes.
A major challenge to management of AKI after cardiac surgery and cardiopulmonary bypass is the lack of early diagnostic markers. Current diagnostic criteria for AKI in children relies exclusively on elevation of serum creatinine concentration and oliguria. Both of these markers lack sensitivity and specificity, and result in delayed detection of kidney injury.
This study aims to determine if UDP-glucose can be used as a urinary biomarker to detect subclinical acute kidney injury following pediatric cardiac surgery with cardiopulmonary bypass.
- Conditions
- Acute Kidney Injury
- Being tested
- Discarded urine sample
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discarded urine sampleOther
Collection of discarded urine during surgery and following surgery
| Study group | Role | What they receive |
|---|---|---|
| AKI Group | Patients developing AKI after surgery Receives: Other: Discarded urine sample | |
| No AKI Group | Patients who do not develop AKI after surgery Receives: Other: Discarded urine sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
AKI
development of AKI
Measured: within 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start25 Oct 2017
- Primary completion28 Jun 2023
- Study completion1 Feb 2027 (estimated)
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 Boston Children's 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douglas Atkinson, Boston Children's Hospital
- Investigators
- Douglas Atkinson, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263325
- Sponsor's protocol ID
- IRB-P00025852
- Status last verified
- May 2026
- First submitted
- 24 Aug 2017
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of UDP-glucose as a Urinary Biomarker for Early Detection of Cardiac Surgery-associated Pediatric Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT03263325
- Acronym / sponsor ID
- IRB-P00025852
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 28 Aug 2017 (actual)
- 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.
Acute kidney injury (AKI) is common in children after cardiac surgery with a reported incidence of 20-40%. Pediatric AKI has been found to be associated with important short and long-term adverse outcomes.
A major challenge to management of AKI after cardiac surgery and cardiopulmonary bypass is the lack of early diagnostic markers. Current diagnostic criteria for AKI in children relies exclusively on elevation of serum creatinine concentration and oliguria. Both of these markers lack sensitivity and specificity, and result in delayed detection of kidney injury.
This study aims to determine if UDP-glucose can be used as a urinary biomarker to detect subclinical acute kidney injury following pediatric cardiac surgery with cardiopulmonary bypass.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AKI Group | – | Other: Discarded urine samplePatients developing AKI after surgery |
| No AKI Group | – | Other: Discarded urine samplePatients who do not develop AKI after surgery |
Who may qualify
- Ages
- Up to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children ≤ 8 years of age having cardiac surgery with cardiopulmonary bypass
Key inclusion criteria (2 listed)
- less than or equal to 8 years of age
- scheduled for cardiac surgery
Key exclusion criteria (1 listed)
- severe pre-existing renal insufficiency
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 |
|---|---|---|
| Discarded urine sampleCollection of discarded urine during surgery and following surgery | Other | AKI Group, No AKI Group |
Primary outcome
AKI
Time frame: within 72 hours after surgery
development of AKI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
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.
Douglas Atkinson, MD principal investigator
Boston 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 Boston Children's Hospital at 1 site in United States.
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 2 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 19 May 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
AKI (time frame: within 72 hours after surgery). 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 19 May 2026.