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NCT04008810Completed

Serum Neutrophil Gelatinase-associated Lipocalins (NGAL) and Chronic Kidney Disease

Serum Neutrophil Gelatinase-associated Lipocalins (NGAL) Ability to Predict Chronic Kidney Disease and the Number of Readmissions in Patients Admitted in the Emergency Department - a Longitudinal Prospective Study

Source: ClinicalTrials.gov · Last updated 25 Feb 2025

Brief summary (registry, in English)

Acute kidney injury (AKI) is associated with significant morbidity and mortality, and because no specific treatment is available, early acknowledgment is needed. The incidence of AKI and chronic kidney disease (CKD) have been increasing over time but it is not until the past decade there is an understanding of a bidirectional nature between AKI and CKD, where AKI predisposes to CKD and vice versa. The criteria for diagnosing AKI is through serum creatinine (sCr) and/or urine output. As detection of sCr-increases are delayed by 48-72 hours it is not an optimal biomarker for early recognition of AKI. In contrast the biomarker neutrophil gelatinase-associated lipocalin (NGAL) has shown to predict AKI within 12h of critical disease or postoperative, and without the requirement of prior measurements for comparison. The purpose of the project is to investigate if the relatively new biomarker NGAL (neutrophil gelatinase-associated lipocalin), which is known to be able to detect AKI in an early phase, can be used to detect development of CKD and potential future hospital admissions in a relatively large and diverse cohort of patients admitted to the Acute Emergency Department at North Zealand Hospital. The study is designed as a longitudinal prospective study where there is an enrollment estimation of 3600 unselected patients over one year. Blood tests will be taken when admitted and thereafter every day for the first week and subsequently every once a week throughout hospitalization. Patients that are sent home the same day, will still be included in the study but without further NGAL analyses.

Status (registry)
Completed
Study type
Observational
Enrollment
1032 (actual)
First submitted
1 Jul 2019
Start date
3 Oct 2019
Primary completion date
10 Jan 2023
Lead sponsor
Hillerod Hospital, Denmark
NCT number
NCT04008810

What you commit to

  • Study type: Observational
  • Participants enrolled: 1032
  • From 3 Oct 2019 to the primary completion date, 10 Jan 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Admitted through pediatric-, gynecologic-, obstetric department and intensive care unit

Who the study is looking for

  • Written informed consent and
  • Male or female aged \>= 18 years and
  • Admitted to the ED at North Zealand University Hospitals, on one of the three chosen days of the month
  • At least one valid delta-creatinine

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
North Zealand Hospital
Coordinator of this site? Confirm its status
HillerødDenmarkUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.