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NCT03541785: Taking Focus 2

Use of NGAL for Fluid Dosing and CRRT Initiation in Pediatric AKI

ENROLLING BY INVITATION Last updated 23 March 2026
What this trial tests

trial in Acute Kidney Injury in 420 participants. Enrolling by invitation.

Timeline
1 July 2018
Primary endpoint
30 June 2028
30 June 2029

Quick facts

Lead sponsorChildren's Hospital Medical Center, Cincinnati
StatusENROLLING BY INVITATION
Study typeOBSERVATIONAL
Enrollment420
Start date1 July 2018
Primary completion30 June 2028
Estimated completion30 June 2029
Sites1 location across United States

Conditions studied

Sponsor

Children's Hospital Medical Center, Cincinnati

Who can join

Adults 3 Months to 25, any sex, with Acute Kidney Injury or Renal Replacement Therapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Real-Time Acute Kidney Injury Risk Stratification-Biomarker Directed Fluid Management Improves Outcomes in Critically Ill Children and Young Adults.
    Goldstein SL, Krallman KA, Roy JP, Collins M, et al · · 2023 · cited 49× · PMID 38106571 · DOI 10.1016/j.ekir.2023.09.019
  2. Fluid assessment, fluid balance, and fluid overload in sick children: a report from the Pediatric Acute Disease Quality Initiative (ADQI) conference.
    Selewski DT, Barhight MF, Bjornstad EC, Ricci Z, et al · · 2024 · cited 34× · PMID 37934274 · DOI 10.1007/s00467-023-06156-w
  3. Integration of the Renal Angina Index and Urine Neutrophil Gelatinase-Associated Lipocalin Improves Severe Acute Kidney Injury Prediction in Critically Ill Children and Young Adults.
    Goldstein SL, Krallman KA, Kirby C, Roy JP, et al · · 2022 · cited 22× · PMID 35967111 · DOI 10.1016/j.ekir.2022.05.021
  4. Improving acute kidney injury diagnostic precision using biomarkers.
    Hasson D, Menon S, Gist KM. · · 2022 · cited 15× · PMID 35494424 · DOI 10.1016/j.plabm.2022.e00272
  5. Acute kidney injury biomarker olfactomedin 4 predicts furosemide responsiveness.
    Hasson DC, Zhang B, Krallman K, Rose JE, et al · · 2023 · cited 12× · PMID 37010559 · DOI 10.1007/s00467-023-05920-2
  6. A risk-stratified assessment of biomarker-based acute kidney injury phenotypes in children.
    Stanski NL, Krallman KA, Chima RS, Goldstein SL. · · 2023 · cited 10× · PMID 35933485 · DOI 10.1038/s41390-022-02233-2
  7. Early Sequential Risk Stratification Assessment to Optimize Fluid Dosing, CRRT Initiation and Discontinuation in Critically Ill Children with Acute Kidney Injury: Taking Focus 2 Process Article.
    Roy JP, Krallman KA, Basu RK, Chima RS, et al · · 2020 · cited 9× · PMID 34476130
  8. Renal angina index predicts fluid overload in critically ill children: an observational cohort study.
    Gorga SM, Carlton EF, Kohne JG, Barbaro RP, et al · · 2021 · cited 6× · PMID 34635072 · DOI 10.1186/s12882-021-02540-6

Verify or expand the search:

Other recruiting trials for Acute Kidney Injury

Currently open trials in the same condition.

Other Children's Hospital Medical Center, Cincinnati trials

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03541785.

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