Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20249, Germany
Location status: Recruiting
NCT Number: NCT07338669
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Hamburg, 20249, Germany
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: assessed at discharge, 3-months after discharge, and annual follow-up
Death attributable to kidney-related causes as determined by medical record review.
Time frame: assessed at discharge, 3-months after discharge, and annual follow-up
cardiovascular death, myocardial infarction, heart failure, arrhythmia, stroke
Time frame: 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
Time frame: assessed at discharge, 3 months after discharge, and annual follow-up
New diagnosis of dementia occurring during follow-up after AKI
Time frame: assessed at discharge, 3 months after discharge, and annual follow-up
New diagnosis of malignant disease occurring during follow-up after AKI
Time frame: assessed at discharge, 3 months after discharge, and annual follow-up
New diagnosis of infections occurring during follow-up after AKI
Time frame: assessed at discharge, 3 months after discharge, and annual follow-up
New diagnosis of psychosomatic or psychiatric disorders occurring during follow-up after AKI
Contact information is provided by the study sponsor or research team.
Christian Schmidt-Lauber, MD
CONTACT
Maja Lindenmeyer, PhD
CONTACT
Universitätsklinikum Hamburg-Eppendorf
Other
Hamburg Acute Renal Injury Study
Acronym: HARIS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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