Hamburg Acute Renal Injury Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Kidney Function Recovery after AKI
研究概览
简要总结
The Hamburg Acute Renal Injury Study (HARIS) is a prospective observational cohort study aimed at investigating the mechanisms, risk factors, and clinical determinants of acute kidney injury (AKI) trajectories and consequences.
详细描述
The Hamburg Acute Renal Injury Study (HARIS) is a prospective observational cohort study that includes hospitalized adults (≥18 years) at the time of acute kidney injury (AKI). Potential participants are identified during hospital care, and a structured IT-supported clinical screening system helps detect AKI cases in real time. In parallel, a control group of hospitalized adults with acute illness who have not developed AKI is enrolled to enable comparative analyses of specific risk factors, pathophysiology, and outcomes. All participants undergo a standardized clinical assessment of kidney function, comorbidities, hemodynamic status, medication exposure, procedures, and laboratory parameters. The study includes serial collection of clinical data and biosamples (blood and urine) at study inclusion, during hospitalization, and at 3-month after discharge. All biospecimens are processed within a harmonized pipeline and stored in the Hamburg and European Renal Omics-Biobank (HERO). Beyond the identification of clinical determinants of AKI trajectories, the central objective of HARIS is to identify biological pathways of sustained kidney injury and repair, improve risk stratification, evaluated prognostic biomarkers, and support the development of precision medicine approaches in post AKI care. Long-term outcomes including progressive chronic kidney disease, cardiovascular events, hospital readmissions, and mortality are collected through annual structured follow-ups. No experimental interventions are performed and all clinical management follows standard of care.
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
- 否
入选标准
- •Hospitalized individuals with acute kidney injury (AKI), defined by the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) criteria or hospitalized individuals with acute illness who have not developed AKI (control group)
- •Age ≥ 18 years at time of enrollment
- •Personally signed informed consent
排除标准
- 未提供
研究组 & 干预措施
AKI group
Group consists of adult hospitalized individuals, who meet the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) criteria for acute kidney injury (AKI). Participants will be prospectively followed for clinical course, kidney function, biomarker analysis, and outcomes. No experimental interventions are performed. All care follows standard clinical practice.
Control group
Group consists of adult hospitalized individuals with an acute illness, who have not developed acute kidney injury (AKI). Participants will be prospectively followed for clinical course, kidney function, biomarker analysis, and outcomes. No experimental interventions are performed. All care follows standard clinical practice.
结局指标
主要结局
Kidney Function Recovery after AKI
时间窗: assessed at discharge, 3-months after discharge, and annual follow-up
Improvement of kidney function after acute kidney injury, defined by partial or complete return of the kidney function toward baseline values
Persistent Kidney Function Decline
时间窗: assessed at discharge, 3-months after discharge, and annual follow-up
Sustained impairment of kidney function following acute kidney injury, characterized by incomplete recovery and persistently reduced kidney function over follow-up.
Development or Progression of Chronic Kidney Disease
时间窗: assessed at 3-months after discharge, and annual follow-up
New onset or worsening of chronic kidney disease during follow-up, assessed based on changes in kidney function over time.
End-stage kidney disease (ESKD)
时间窗: assessed at discharge, 3-months after discharge, and annual follow-up
Occurrence of ESKD, characterized by the initiation of maintenance kidney replacement therapy, kidney transplantation or a persistent eGFR \< 15 ml/min/1.73m2
Renal mortality
时间窗: assessed at discharge, 3-months after discharge, and annual follow-up
Death attributable to kidney-related causes as determined by medical record review.
Cardiovascular Outcomes
时间窗: assessed at discharge, 3-months after discharge, and annual follow-up
cardiovascular death, myocardial infarction, heart failure, arrhythmia, stroke
次要结局
- Incidence of vascular diseases(assessed at discharge, 3 months after discharge, and annual follow-up)
- Incidence of Dementia(assessed at discharge, 3 months after discharge, and annual follow-up)
- Incidence of Cancer(assessed at discharge, 3 months after discharge, and annual follow-up)
- Incidence of Infections(assessed at discharge, 3 months after discharge, and annual follow-up)
- Incidence of psychosomatic or Psychiatric Disorders(assessed at discharge, 3 months after discharge, and annual follow-up)
