Hamburg Acute Renal Injury Study (HARIS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Kidney Injury, Acute Kidney Injury (AKI). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Hamburg Acute Renal Injury Study
Overview
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.
Primary outcome measures
- Kidney Function Recovery after AKI [Time frame: assessed at discharge, 3-months after discharge, and annual follow-up]
- Persistent Kidney Function Decline [Time frame: assessed at discharge, 3-months after discharge, and annual follow-up]
- Development or Progression of Chronic Kidney Disease [Time frame: assessed at 3-months after discharge, and annual follow-up]
- End-stage kidney disease (ESKD) [Time frame: assessed at discharge, 3-months after discharge, and annual follow-up]
- Renal mortality [Time frame: assessed at discharge, 3-months after discharge, and annual follow-up]
- Cardiovascular Outcomes [Time frame: assessed at discharge, 3-months after discharge, and annual follow-up]
Secondary outcome measures (5)
- Incidence of vascular diseases [Time frame: assessed at discharge, 3 months after discharge, and annual follow-up]
- Incidence of Dementia [Time frame: assessed at discharge, 3 months after discharge, and annual follow-up]
- Incidence of Cancer [Time frame: assessed at discharge, 3 months after discharge, and annual follow-up]
- Incidence of Infections [Time frame: assessed at discharge, 3 months after discharge, and annual follow-up]
- Incidence of psychosomatic or Psychiatric Disorders [Time frame: assessed at discharge, 3 months after discharge, and annual follow-up]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Universitätsklinikum Hamburg-Eppendorf — Hamburg
Identifiers
NCT: NCT07338669 · PV6037-4337-BO-ff HARIS