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Prevention of Acute Kidney Injury Through Biomarker-guided Nephrological Intervention

Prevention of Acute Kidney Injury Through Biomarker-guided Nephrological

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02730637
Enrollment
100
Registered
2016-04-06
Start date
2016-03-31
Completion date
2017-11-30
Last updated
2017-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

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.

Detailed description

This study examines the impact of an early biomarker-guided intervention on the development of acute kidney injury (AKI). New biomarkers indicate kidney damage in an early stage before developing acute kidney injury according to AKI Kidney Disease Improving Global Outcomes (KDIGO) Definition is detectable. The investigators want to test if it's possible to prevent AKI based on elevated urinary biomarkers. Eligible patients will be randomly assigned to two groups, a control and an intervention Group by an early nephrologic consultation. The interventional group will receive an early preventive nephrologist consultation additionally to standard care.

Interventions

OTHEREarly nephrologist consultation

Sponsors

Robert Bosch Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Incidence of AKI in both groups according to AKI KDIGO definitionwithin 24 hours

Secondary

MeasureTime frame
Need for renal replacement therapywithin 24 hours
Length of hospital staywithin 30 days
Severity of AKI in both groups according to AKI KDIGO definitionwithin 30 days
Incidence of AKI in both groups according to AKI KDIGO definitionwithin 72 hours
Severety of AKI in both groups according to AKI KDIGO definitionwithin 72 hours
Deathwithin 30 days

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026