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NCT Number: NCT07338669

Hamburg Acute Renal Injury Study (HARIS)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Kidney Function Recovery after AKI

    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

  2. Persistent Kidney Function Decline

    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.

  3. Development or Progression of Chronic Kidney Disease

    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.

  4. End-stage kidney disease (ESKD)

    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

  5. Renal mortality

    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.

  6. Cardiovascular Outcomes

    Time frame: assessed at discharge, 3-months after discharge, and annual follow-up

    cardiovascular death, myocardial infarction, heart failure, arrhythmia, stroke

Secondary outcomes

  1. Incidence of vascular diseases

    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

  2. Incidence of Dementia

    Time frame: assessed at discharge, 3 months after discharge, and annual follow-up

    New diagnosis of dementia occurring during follow-up after AKI

  3. Incidence of Cancer

    Time frame: assessed at discharge, 3 months after discharge, and annual follow-up

    New diagnosis of malignant disease occurring during follow-up after AKI

  4. Incidence of Infections

    Time frame: assessed at discharge, 3 months after discharge, and annual follow-up

    New diagnosis of infections occurring during follow-up after AKI

  5. Incidence of psychosomatic or Psychiatric Disorders

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Christian Schmidt-Lauber, MD

CONTACT

[email protected]

+49 (0) 40 7410 53908

Maja Lindenmeyer, PhD

CONTACT

[email protected]

+49 (0) 40 7410 53908

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

Hamburg Acute Renal Injury Study

Acronym: HARIS

Important dates

Study start
2025
Primary completion
2026
Study completion
2030
First posted
Jan 14, 2026
Registry last updated
Jan 14, 2026

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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