Prevention of Acute Kidney Injury Through Biomarker-guided Nephrological Intervention

Not Applicable

Completed

• Conditions: Acute Kidney Injury

• Registration Number: NCT02730637
• Lead Sponsor: Robert Bosch Medical Center

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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-18
• Study First Submitted QC: 2016-03-31
• Study First Posted: 2016-04-06
• Primary Completion: 2017-10
• Study Completion: 2017-11
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-14
• Last Update Posted: 2017-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of AKI in both groups according to AKI KDIGO definition	within 24 hours

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	within 60 days
Severity of AKI in both groups according to AKI KDIGO definition	within 60 days
Need for renal replacement therapy	within 60 days
Severety of AKI in both groups according to AKI KDIGO definition	within 72 hours
Incidence of AKI in both groups according to AKI KDIGO definition	within 60 days
Death	within 60 days

Trial Locations

Locations (1)

Robert-Bosch Hospital; 🇩🇪 Stuttgart, Germany