Hamburg Acute Kidney Injury Study (HAKIS)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitätsklinikum Hamburg-Eppendorf
About this trial
The Hamburg Acute Kidney Injury Study (HAKIS) is a prospective observational cohort study aimed at investigating the mechanisms, risk factors, and clinical determinants of acute kidney injury (AKI) trajectories and consequences.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Written informed consent provided by the participant or, in participants lacking decision-making capacity, by a legal representative or healthcare proxy, where available. Participants lacking decision-making capacity without an available legal representative or healthcare proxy may be enrolled if participation is not contrary to their presumed wishes, in accordance with the ethics committee-approved consent procedure. Written informed consent is subsequently sought from the participant upon regaining decision-making capacity or from a legal representative, as applicable.
Disqualifiers
None
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 2 trial groupsGroup A: AKI group
Group B: Control group
Trial outcomes
Primary outcomes
1
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
Time frame
assessed at discharge, 3-months after discharge, and annual follow-up2
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.
Time frame
assessed at discharge, 3-months after discharge, and annual follow-up3
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.
Time frame
assessed at 3-months after discharge, and annual follow-up4
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
Time frame
assessed at discharge, 3-months after discharge, and annual follow-upSecondary outcomes
1
Incidence of vascular diseases
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-up2
Incidence of Dementia
New diagnosis of dementia occurring during follow-up after AKI
Time frame
assessed at discharge, 3 months after discharge, and annual follow-up3
Incidence of Cancer
New diagnosis of malignant disease occurring during follow-up after AKI
Time frame
assessed at discharge, 3 months after discharge, and annual follow-up4
Incidence of Infections
New diagnosis of infections occurring during follow-up after AKI
Time frame
assessed at discharge, 3 months after discharge, and annual follow-upSponsors and contacts
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Source ClinicalTrials.gov