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临床试验/NCT04008810
NCT04008810已完成不适用

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

Hillerod Hospital, Denmark1 个研究点 分布在 1 个国家目标入组 1,032 人开始时间: 2019年10月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,032
试验地点
1
主要终点
Development of chronic kidney disease (CKD)

研究概览

简要总结

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.

详细描述

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. There will be follow-up time in all patients included in the study, up to one year after admission through the Danish National Patient Register and medical journals to see if the patients are reinstated, what they are diagnosed with and if they have had other hospital contacts. This will further be done to examine if NGAL is better at predicting the number of hospital contacts, up to one year after discharge.

Primary endpoint:

If NGAL can predict development of CKD defined as eGFR < 60ml/min per 1.73 m^2 and/or albumin/creatinine ratio >= 30mg/g over 3 months in patients upfilling the AKI criteria with a delta-creatinine >= 26,5 umol/l during the initial hospital admission, within one year from first admission. Cystatin C values will be compared to NGAL.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Development of chronic kidney disease (CKD)

时间窗: up to one year from first admission

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

次要结局

未报告次要终点

研究者

发起方
Hillerod Hospital, Denmark
申办方类型
Other
责任方
Principal Investigator
主要研究者

Vicky Jenny Rebecka Wetterstrand

Principal Investigator and Physician

Nordsjaellands Hospital

研究点 (1)

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