Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Kidney Function Recovery after AKI | Improvement of kidney function after acute kidney injury, defined by partial or complete return of the kidney function toward baseline values | assessed at discharge, 3-months after discharge, and annual follow-up |
| Persistent Kidney Function Decline | Sustained impairment of kidney function following acute kidney injury, characterized by incomplete recovery and persistently reduced kidney function over follow-up. | assessed at discharge, 3-months after discharge, and annual follow-up |
| Development or Progression of Chronic Kidney Disease | New onset or worsening of chronic kidney disease during follow-up, assessed based on changes in kidney function over time. | assessed at 3-months after discharge, and annual follow-up |
| End-stage kidney disease (ESKD) | Occurrence of ESKD, characterized by the initiation of maintenance kidney replacement therapy, kidney transplantation or a persistent eGFR < 15 ml/min/1.73m2 | assessed at discharge, 3-months after discharge, and annual follow-up |
| Renal mortality | Death attributable to kidney-related causes as determined by medical record review. | assessed at discharge, 3-months after discharge, and annual follow-up |
| Cardiovascular Outcomes | cardiovascular death, myocardial infarction, heart failure, arrhythmia, stroke | assessed at discharge, 3-months after discharge, and annual follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of vascular diseases | Occurrence of vascular disease, including coronary artery disease, peripheral artery disease, or cerebrovascular disease after AKI | assessed at discharge, 3 months after discharge, and annual follow-up |
| Incidence of Dementia |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Hospitalized individuals with acute kidney injury (AKI) or at risk for AKI will be identified during routine medical care and invited for study participation. Routine clinical identification of AKI includes an IT-based screening system.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian Schmidt-Lauber, MD | Contact | +49 (0) 40 7410 53908 | c.schmidt-lauber@uke.de | |
| Maja Lindenmeyer, PhD | Contact | +49 (0) 40 7410 53908 | m.lindenmeyer@uke.de |
| Name | Affiliation | Role |
|---|---|---|
| Tobias B Huber, MD | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Hamburg-Eppendorf | Recruiting | Hamburg | 20249 | Germany |
Not provided
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
plasma (EDTA), serum, blood cells, urine
New diagnosis of dementia occurring during follow-up after AKI |
| assessed at discharge, 3 months after discharge, and annual follow-up |
| Incidence of Cancer | New diagnosis of malignant disease occurring during follow-up after AKI | assessed at discharge, 3 months after discharge, and annual follow-up |
| Incidence of Infections | New diagnosis of infections occurring during follow-up after AKI | assessed at discharge, 3 months after discharge, and annual follow-up |
| Incidence of psychosomatic or Psychiatric Disorders | New diagnosis of psychosomatic or psychiatric disorders occurring during follow-up after AKI | assessed at discharge, 3 months after discharge, and annual follow-up |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |