Hamburg Acute Kidney Injury Study (HAKIS)

NCT07338669 | Recruiting

• 1 other identifier: PV6037-4337-BO-ff HAKIS
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Kidney Injury; Acute Kidney Injury (AKI)

Keywords

Acute Kidney Injury; AKI; Prospective observational cohort study

Outcome Measures

Primary Outcomes (6)

• 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

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

• 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.

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

• 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.

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

• 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

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

• Renal mortality

  Death attributable to kidney-related causes as determined by medical record review.

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

• Cardiovascular Outcomes

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

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

Secondary Outcomes (5)

• Incidence of vascular diseases

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

• Incidence of Dementia

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

• Incidence of Cancer

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

• Incidence of Infections

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

• Incidence of psychosomatic or Psychiatric Disorders

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

Study Arms (2)

AKI group

Group consists of adult hospitalized individuals, who meet the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) criteria for acute kidney injury (AKI). Participants will be prospectively followed for clinical course, kidney function, biomarker analysis, and outcomes. No experimental interventions are performed. All care follows standard clinical practice.

Control group

Group consists of adult hospitalized individuals with an acute illness, who have not developed acute kidney injury (AKI). Participants will be prospectively followed for clinical course, kidney function, biomarker analysis, and outcomes. No experimental interventions are performed. All care follows standard clinical practice.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20249, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

plasma (EDTA), serum, blood cells, urine

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Tobias B Huber, MD

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Schmidt-Lauber, MD

CONTACT

+49 (0) 40 7410 53908; c.schmidt-lauber@uke.de

Maja Lindenmeyer, PhD

CONTACT

+49 (0) 40 7410 53908; m.lindenmeyer@uke.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: January 14, 2026
• Study Start: September 16, 2025
• Primary Completion: September 1, 2026
• Study Completion (Estimated): September 1, 2030
• Last Updated: October 1, 2026

Record last verified: 2026-09

Locations

DE (1)