Acute Kidney InjuryTaking Focus 2NCT05114057
Use of NGAL for Fluid Dosing and CRRT Initiation in Pediatric and Neonatal AKI
A study testing Renal Angina Index (RAI) in people with Acute Kidney Injury and Acute Kidney Injury Due to Sepsis, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
This study will follow patients admitted to the PICU with sepsis, NICU with sepsis or after abdominal surgery, or CICU who are identified as being at risk for developing acute kidney injury. Read more about this study
- Who is it for?
- Ages Up to 25 years
- Conditions the study is for
- Acute Kidney Injury, Acute Kidney Injury Due to Sepsis, Neonatal Sepsis
- What is being tested?
- Renal Angina Index (RAI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2026to 1 Jul 2029
- Phase
- Interventional
- 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 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Admitted to the Pediatric Intensive Care Unit (PICU), Cardiac Intensive Care Unit (CICU), or Neonatal Intensive Care Unit (NICU) at participating institution
Who cannot join
- Baseline Chronic Kidney Disease (CKD) Stage IV or V (estimated GFR <60 mL/min/1.736m2)
- History of kidney transplant within the previous 90 days
- Ongoing AKI or Acute Kidney Disease (AKD) at ICU admission requiring renal replacement therapy initiated prior to ICU admission
- Acute DNR order or clinical team is not committed to escalating medical care
- Anticipated to require intensive care for less than 48 hours
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Use of NGAL to Optimize Fluid Dosing, CRRT Initiation and Discontinuation in Critically Ill Children and Neonates With Acute Kidney Injury
This study will follow patients admitted to the PICU with sepsis, NICU with sepsis or after abdominal surgery, or CICU who are identified as being at risk for developing acute kidney injury. The investigators will use risk-stratification, biomarker testing, and a functional assessment to predict children and neonates who will become fluid overloaded and develop severe acute kidney injury.
Read the detailed description
In the pediatric population, acute kidney injury (AKI) is commonly observed in critically ill patients. At this time, there are no standardized care pathways that begin at identifying patients at risk for developing AKI and progress through to early recognition and treatment. Through previous work, the investigators have integrated a risk-stratification tool (renal angina index or RAI) and a urine biomarker (NGAL) to try to identify PICU patients at risk versus not at-risk for developing AKI. Through this study, the investigators will tailor the RAI to the septic population in the PICU, create a new NICU RAI, and investigate the utility of the CICU specific RAI in a prospective population. Biomarker testing will be used to further risk-stratify those patients deemed at highest risk through the RAI.
- Being tested
- Renal Angina Index (RAI)
- Keywords
- Renal Angina Index, NGAL
- Medical subject headings
- Acute Kidney Injury, Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal Angina Index (RAI)Other
Risk-stratification tool using measures of risk and presence of injury to predict Acute Kidney Injury
| Study group | Role | What they receive |
|---|---|---|
| PICU Patients | Other | Prospectively enrolled patients admitted to the PICU will be assessed by the RAI calibration for sepsis in the PICU and including additional risk factors. Receives: Other: Renal Angina Index (RAI) |
| CICU Patients | Other | Prospectively enrolled patients admitted to the CICU will be assessed by the RAI calibration specific to the CICU, especially post cardiac bypass Receives: Other: Renal Angina Index (RAI) |
| NICU Patients | Other | Prospectively enrolled patients admitted to the NICU will be assessed by the RAI calibration for neonatal patients with sepsis or post abdominal surgeries Receives: Other: Renal Angina Index (RAI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Decision Support Performance
Accuracy of the risk stratification and biomarker testing to rule out Acute Kidney Injury at ICU Days 2-4 as measured by the negative predictive value (NPV)
Measured: Days 2-4 after ICU admission
Secondary outcomes (1)
Rate of Clinical Decision Support Completion
Time to complete the risk stratification and biomarker testing is less than 48 hours
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study startMar 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion1 Jul 2029 (estimated)
Why it stopped: Inadequate funding
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 Children's Hospital Medical Center, CincinnatiThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stuart L Goldstein, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114057
- Sponsor's protocol ID
- CIN002 - Taking Focus 3
- Acronym
- Taking Focus 2
- Status last verified
- Mar 2026
- First submitted
- 20 Oct 2021
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of NGAL to Optimize Fluid Dosing, CRRT Initiation and Discontinuation in Critically Ill Children and Neonates With Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT05114057
- Acronym / sponsor ID
- Taking Focus 2 / CIN002 - Taking Focus 3
- Keywords
- Renal Angina Index, NGAL
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inadequate funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 9 Nov 2021 (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.
This study will follow patients admitted to the PICU with sepsis, NICU with sepsis or after abdominal surgery, or CICU who are identified as being at risk for developing acute kidney injury. The investigators will use risk-stratification, biomarker testing, and a functional assessment to predict children and neonates who will become fluid overloaded and develop severe acute kidney injury.
Detailed description
In the pediatric population, acute kidney injury (AKI) is commonly observed in critically ill patients. At this time, there are no standardized care pathways that begin at identifying patients at risk for developing AKI and progress through to early recognition and treatment. Through previous work, the investigators have integrated a risk-stratification tool (renal angina index or RAI) and a urine biomarker (NGAL) to try to identify PICU patients at risk versus not at-risk for developing AKI. Through this study, the investigators will tailor the RAI to the septic population in the PICU, create a new NICU RAI, and investigate the utility of the CICU specific RAI in a prospective population. Biomarker testing will be used to further risk-stratify those patients deemed at highest risk through the RAI.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PICU Patients | Other | Other: Renal Angina Index (RAI)Prospectively enrolled patients admitted to the PICU will be assessed by the RAI calibration for sepsis in the PICU and including additional risk factors. |
| CICU Patients | Other | Other: Renal Angina Index (RAI)Prospectively enrolled patients admitted to the CICU will be assessed by the RAI calibration specific to the CICU, especially post cardiac bypass |
| NICU Patients | Other | Other: Renal Angina Index (RAI)Prospectively enrolled patients admitted to the NICU will be assessed by the RAI calibration for neonatal patients with sepsis or post abdominal surgeries |
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Admitted to the Pediatric Intensive Care Unit (PICU), Cardiac Intensive Care Unit (CICU), or Neonatal Intensive Care Unit (NICU) at participating institution
Key exclusion criteria (5 listed)
- Baseline Chronic Kidney Disease (CKD) Stage IV or V (estimated GFR <60 mL/min/1.736m2)
- History of kidney transplant within the previous 90 days
- Ongoing AKI or Acute Kidney Disease (AKD) at ICU admission requiring renal replacement therapy initiated prior to ICU admission
- Acute DNR order or clinical team is not committed to escalating medical care
- Anticipated to require intensive care for less than 48 hours
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 |
|---|---|---|
| Renal Angina Index (RAI)Risk-stratification tool using measures of risk and presence of injury to predict Acute Kidney Injury | Other | CICU Patients, NICU Patients, PICU Patients |
Primary outcome
Clinical Decision Support Performance
Time frame: Days 2-4 after ICU admission
Accuracy of the risk stratification and biomarker testing to rule out Acute Kidney Injury at ICU Days 2-4 as measured by the negative predictive value (NPV)
1 secondary outcome
Rate of Clinical Decision Support Completion
Time frame: 48 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: Undecided
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.
Stuart L Goldstein, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal Angina Index (RAI) in people with Acute Kidney Injury and Acute Kidney Injury Due to Sepsis, run by Children's Hospital Medical Center, Cincinnati 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 1 inclusion and 5 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: withdrawn, as of the sponsor's last update on 24 Mar 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Clinical Decision Support Performance (time frame: Days 2-4 after ICU admission). 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 24 Mar 2026.