The Hamburg Acute Kidney Injury Study 

The Hamburg Acute Kidney Injury Study (HAKIS) is a prospective observational cohort study that aims to improve the understanding of health outcomes after acute kidney injury (AKI). AKI affects up to one in five hospitalized patients and is associated with short- and long-term consequences, including chronic kidney disease, cardiovascular complications, and increased mortality.1-4 HAKIS focuses on understanding how kidney function evolves after AKI, why some patients recover while others do not, and which clinical and biological factors influence short- and long-term outcomes.

Study Characteristics

Why:

  • Acute kidney injury (AKI) is common but often under-recognized5
  • After AKI, patients are at increased risk of short- and long-term adverse outcomes
  • Evidence-based strategies to monitor or manage patients after AKI are sparse
  • HAKIS aims to provide new knowledge that helps estimating short- and long-term risks and improve follow-up care

Study Aims:

  • Characterize kidney, cardiovascular, and general health outcomes after AKI
  • Evaluate biomarkers associated with adverse outcomes of AKI
  • Identify clinical and biological factors associated with recovery or progression to chronic kidney disease
  • Support the development of risk-based follow-up care for AKI survivors

Study Overview:

  • HAKIS includes hospitalized adults with AKI
  • A control group of hospitalized adults with acute illness but without AKI is also incorporated
  • Participants are followed over time to understand kidney disease recovery, progression, and outcomes

Study Characteristics:

Structured Patient Follow-up: Participants with AKI receive standardized evaluations during and after hospitalization to monitor kidney function and general health.

Participant Safety and Ethics: No study-specific treatments or interventions are performed. Data are primarily collected from routine clinical care and - whenever possible - directly obtained from electronic health records to minimize the burden for participants. The study adheres to strict ethical standards and follows General Data Protection Regulation (GDPR)-compliant data protection protocols.

Integrated Biobanking: Blood and urine samples collected during the study are processed using standardized procedures and stored in the Hamburg and European Renal Omics Biobank (HERO) according to strict data protection protocols to enable future kidney research.

Transparency and Scientific Quality: HAKIS is registered on ClinicalTrials.gov (Identifier: NCT07338669) and follows international guidelines for clinical research quality and reporting.

Contribution to Global Kidney Research: By generating high-quality clinical data and biological samples, HAKIS supports national and international research efforts aimed at improving risk prediction, prognosis, and long-term care after AKI.
Detailed Study Description
HAKIS is a prospective observational cohort study that includes hospitalized adults (≥18 years) at the time they experience acute kidney injury (AKI). Potential participants are identified during hospital care, and a structured IT-supported clinical screening system helps detect cases of AKI in real time. To allow comparison, a control group of hospitalized patients with acute illness but without AKI is also incorporated. This helps identify risk factors and mechanisms that are specific to AKI.
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 predefined time points:
  • At AKI diagnosis
  • During hospitalization
  • At an outpatient visit 3 months after discharge
All biospecimens are processed according to a harmonized protocol and stored in the Hamburg and European Renal Omics-Biobank (HERO) according to strict data protection protocols for advanced molecular analyses. Whenever possible, study data are obtained directly from electronic health records to minimize burden for participants.
Long-term outcomes including progressive chronic kidney disease, cardiovascular events, hospital readmissions, and mortality are collected through annual structured follow-ups.

For more information, please visit: Study Overview

Contact

 

Study Center

Contact for Participants

  • General Questions and Participant Rights: Study Center, This email address is being protected from spambots. You need JavaScript enabled to view it.
  • Coordination of Follow up: Katja Lange, This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact for Professionals

  • Project Coordination: Dr. Christian Schmidt-Lauber, This email address is being protected from spambots. You need JavaScript enabled to view it.
  • Deputy Project Coordination: Dr. Alexandre Klopp, This email address is being protected from spambots. You need JavaScript enabled to view it.

References

1.
Susantitaphong P, Cruz DN, Cerda J, Abulfaraj M, Alqahtani F, Koulouridis I, Jaber BL; Acute Kidney Injury Advisory Group of the American Society of Nephrology. Clin J Am Soc Nephrol. 2013 Sep;8(9):1482-93. 
2.
Chawla LS, Eggers PW, Star RA, Kimmel PL. N Engl J Med. 2014 Jul 3;371(1):58-66. 
3.
Coca SG, Yusuf B, Shlipak MG, Garg AX, Parikh CR. Am J Kidney Dis. 2009 Jun;53(6):961-73. 
4.
Veltkamp DMJ, Porras CP, Gant CM, Groenestege WMT, Kok MB, Verhaar MC, van Solinge WW, Haitjema S, Vernooij RWM. Nephrol Dial Transplant. 2025 Oct 30;40(11):2143-2158.
5.
Khadzhynov D, Schmidt D, Hardt J, Rauch G, Gocke P, Eckardt KU, Schmidt-Ott KM. Dtsch Arztebl Int. 2019 May 31;116(22):397-404.

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