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

NCT04008810 | Completed DMC

• 1 other identifier: H-19003424
• Study Type: observational
• Target: 1,032
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Diseases; CKD; NGAL; Neutrophil Gelatinase-associated Lipocalin; Emergency Department; AKI; Acute Kidney Injury

Keywords

renal insufficiency; renal failure; acute kidney injury; AKI

Outcome Measures

Primary Outcomes (1)

• Development of chronic kidney disease (CKD)

  Neutrophil Gelatinase-associated Lipocalin (NGAL) in ng/ml

  up to one year from first admission

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Unselected patients admitted through the emergency department

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hillerod Hospital, Denmark: lead
• BioPorto Diagnostics: collaborator

Study Sites (1)

North Zealand Hospital

Hillerød, Denmark

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Emergencies; Acute Kidney Injury; Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Physician

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 5, 2019
• Study Start: October 3, 2019
• Primary Completion: January 10, 2023
• Study Completion: June 3, 2024
• Last Updated: February 25, 2025

Record last verified: 2025-02

Locations

DK (1)