Acute Kidney Injury, Acute Kidney Injury (AKI)
Conditions
Keywords
Acute Kidney Injury, AKI, Prospective observational cohort study
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular Outcomes | assessed at discharge, 3-months after discharge, and annual follow-up | cardiovascular death, myocardial infarction, heart failure, arrhythmia, stroke |
| Development or Progression of Chronic Kidney Disease | 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. |
| Persistent Kidney Function Decline | 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. |
| Kidney Function Recovery after AKI | 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 |
| End-stage kidney disease (ESKD) | 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 | assessed at discharge, 3-months after discharge, and annual follow-up | Death attributable to kidney-related causes as determined by medical record review. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Dementia | assessed at discharge, 3 months after discharge, and annual follow-up | New diagnosis of dementia occurring during follow-up after AKI |
| Incidence of Cancer | assessed at discharge, 3 months after discharge, and annual follow-up | New diagnosis of malignant disease occurring during follow-up after AKI |
| Incidence of Infections | assessed at discharge, 3 months after discharge, and annual follow-up | New diagnosis of infections occurring during follow-up after AKI |
| Incidence of psychosomatic or Psychiatric Disorders | assessed at discharge, 3 months after discharge, and annual follow-up | New diagnosis of psychosomatic or psychiatric disorders occurring during follow-up after AKI |
| Incidence of vascular diseases | assessed at discharge, 3 months after discharge, and annual follow-up | Occurrence of vascular disease, including coronary artery disease, peripheral artery disease, or cerebrovascular disease after AKI |
Countries
Germany
Contacts
Primary ContactChristian Schmidt-Lauber, MD
Backup ContactMaja Lindenmeyer, PhD
Outcome results
None listed