Prevention of Acute Kidney Injury Through Biomarker-guided Nephrological Intervention
1 other identifier
interventional
100
1 country
1
Brief Summary
This study examines the clinical relevance of early biomarkers to detect and prevent acute kidney injury. High-risk patients for developing acute kidney injury will be screened at initial presentation (emergency department and intensive care unit) for TIMP2xIGFBP7. In case of elevated readings patients will be randomized in two arms: The control group will be treated with standard care, the intervention group will receive an early nephrologic consultation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 18, 2016
CompletedFirst Posted
Study publicly available on registry
April 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedDecember 15, 2017
December 1, 2017
1.6 years
March 18, 2016
December 14, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of AKI in both groups according to AKI KDIGO definition
within 24 hours
Secondary Outcomes (14)
Need for renal replacement therapy
within 24 hours
Need for renal replacement therapy
within 72 hours
Need for renal replacement therapy
within 30 days
Need for renal replacement therapy
within 60 days
Length of hospital stay
within 30 days
- +9 more secondary outcomes
Study Arms (2)
Standard care
NO INTERVENTIONPatients with elevated biomarkers receive a standard treatment.
Interventional care
ACTIVE COMPARATORPatients in the interventional population receive an early nephrologist consultation which deliberates with attending doctor on preventing measures according to AKI-KDIGO recommendations.
Interventions
Eligibility Criteria
You may qualify if:
- no acute kidney injury stage II-III (according to AKI KDIGO definition)
- urinary biomarker levels above cut-off
- inpatient treatment
- age ≥18 years
- informed consent or presumed will
You may not qualify if:
- existing acute kidney injury stage II-III (according to AKI KDIGO definition)
- age \< 18 years
- end stage renal disease (ESRD), existing renal replacement therapy
- pregnancy
- withdrawal of consent
- missing presumed will
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Robert-Bosch Hospital
Stuttgart, 70376, Germany
Related Publications (1)
Schanz M, Wasser C, Allgaeuer S, Schricker S, Dippon J, Alscher MD, Kimmel M. Urinary [TIMP-2].[IGFBP7]-guided randomized controlled intervention trial to prevent acute kidney injury in the emergency department. Nephrol Dial Transplant. 2019 Nov 1;34(11):1902-1909. doi: 10.1093/ndt/gfy186.
PMID: 29961888DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Kimmel, MD
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
- PRINCIPAL INVESTIGATOR
Mark Dominik Alscher, MD
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 18, 2016
First Posted
April 6, 2016
Study Start
March 1, 2016
Primary Completion
October 1, 2017
Study Completion
November 1, 2017
Last Updated
December 15, 2017
Record last verified: 2017-12