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临床试验/NCT07338669
NCT07338669招募中不适用

Hamburg Acute Renal Injury Study

Universitätsklinikum Hamburg-Eppendorf1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年9月16日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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