Acute Kidney InjuryTaking Focus 2NCT03541785
Use of NGAL for Fluid Dosing and CRRT Initiation in Pediatric AKI
An observational study of Acute Kidney Injury and Renal Replacement Therapy, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
This study follows a group of patients admitted to the PICU 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 patients who will become fluid overloaded and develop acute kidney injury. Read more about this study
- Who is it for?
- Ages 3 months to 25 years
- Conditions the study is for
- Acute Kidney Injury, Renal Replacement Therapy, Pediatric Intensive Care Units
- How many people
- 420 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 30 Jun 2029
- 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 3 months to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All critically ill patients admitted to the PICU at Cincinnati Children's Hospital Medical Center at risk for developing Acute Kidney Injury
Who may be able to join
- Admitted to the Pediatric Intensive Care Unit (PICU)
- Renal Angina Index (RAI) greater than or equal to 8
- Urine NGAL greater than or equal to 150 ng/mL
- Indwelling urinary catheter
Who cannot join
- Evidence of volume depletion
- Baseline Chronic Kidney Disease (CKD) Stage IV or V (estimated GFR <60 mL/min/1.73m2)
- History of kidney transplantation
- Active DNR order or clinical team is not committed to escalating medical care
- Known history of allergic reaction to furosemide (only for FST)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
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 With Acute Kidney Injury
This study follows a group of patients admitted to the PICU 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 patients who will become fluid overloaded and develop 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 developed, tested, and integrated an AKI risk-stratification/clinical recognition tool (RAI) and a urine biomarker (NGAL) to try to identify patients at risk vs. not at-risk for developing AKI. However, these factors alone have yet to be integrated into clinical decision support to optimize AKI therapies and patient outcomes. The furosemide stress test (FST), previously described in adults, may be a good predictor for the patients who need acute dialysis for AKI versus those that can be managed medically.
Through this study, the investigators will be following a cohort of patients admitted to the PICU who are identified as being at risk for developing AKI through RAI and NGAL results. The aim is to standardize the FST in this population, as well as determine the accuracy of the RAI-NGAL-FST clinical decision tool in predicting patients who become fluid overloaded and develop AKI.
- Keywords
- NGAL, Renal Angina Index
- Medical subject headings
- Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Decision Support Success (CDS)
Time to complete risk stratification (RAI), biomarker testing (NGAL), and functional kidney assessment (FST) is less than 48 hours
Measured: 48 hours of PICU admission
Secondary outcomes (1)
Furosemide Stress Test (FST) Standardization
Validate FST in critically ill pediatric patients, with a standard dose and urinary response
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start1 Jul 2018
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2029 (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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stuart Goldstein, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541785
- Sponsor's protocol ID
- CIN001 - Taking Focus 2
- Other IDs
- 2P50DK096418-06
- Acronym
- Taking Focus 2
- Status last verified
- Mar 2026
- First submitted
- 16 May 2018
- Last updated
- 23 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 23 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 With Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT03541785
- Acronym / sponsor ID
- Taking Focus 2 / CIN001 - Taking Focus 2
- Keywords
- NGAL, Renal Angina Index
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 31 May 2018 (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 follows a group of patients admitted to the PICU 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 patients who will become fluid overloaded and develop 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 developed, tested, and integrated an AKI risk-stratification/clinical recognition tool (RAI) and a urine biomarker (NGAL) to try to identify patients at risk vs. not at-risk for developing AKI. However, these factors alone have yet to be integrated into clinical decision support to optimize AKI therapies and patient outcomes. The furosemide stress test (FST), previously described in adults, may be a good predictor for the patients who need acute dialysis for AKI versus those that can be managed medically.
Through this study, the investigators will be following a cohort of patients admitted to the PICU who are identified as being at risk for developing AKI through RAI and NGAL results. The aim is to standardize the FST in this population, as well as determine the accuracy of the RAI-NGAL-FST clinical decision tool in predicting patients who become fluid overloaded and develop AKI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 months to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All critically ill patients admitted to the PICU at Cincinnati Children's Hospital Medical Center at risk for developing Acute Kidney Injury
Key inclusion criteria (4 listed)
- Admitted to the Pediatric Intensive Care Unit (PICU)
- Renal Angina Index (RAI) greater than or equal to 8
- Urine NGAL greater than or equal to 150 ng/mL
- Indwelling urinary catheter
Key exclusion criteria (5 listed)
- Evidence of volume depletion
- Baseline Chronic Kidney Disease (CKD) Stage IV or V (estimated GFR <60 mL/min/1.73m2)
- History of kidney transplantation
- Active DNR order or clinical team is not committed to escalating medical care
- Known history of allergic reaction to furosemide (only for FST)
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
Clinical Decision Support Success (CDS)
Time frame: 48 hours of PICU admission
Time to complete risk stratification (RAI), biomarker testing (NGAL), and functional kidney assessment (FST) is less than 48 hours
1 secondary outcome
Furosemide Stress Test (FST) Standardization
Time frame: 12 months
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 23 Mar 2026.
- Individual participant dataSharing planned: Undecided
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
AKI (Acute Kidney Injury) Due to Trauma
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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.
Stuart 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?
An observational study of Acute Kidney Injury and Renal Replacement Therapy, 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 4 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: enrolling by invitation, as of the sponsor's last update on 23 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?
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?
Clinical Decision Support Success (CDS) (time frame: 48 hours of PICU 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 23 Mar 2026.