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Clinical Trials/NCT02730637
NCT02730637
Completed
Not Applicable

Prevention of Acute Kidney Injury Through Biomarker-guided Nephrological

Robert Bosch Medical Center1 site in 1 country100 target enrollmentMarch 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Kidney Injury
Sponsor
Robert Bosch Medical Center
Enrollment
100
Locations
1
Primary Endpoint
Incidence of AKI in both groups according to AKI KDIGO definition
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2016
End Date
November 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Robert Bosch Medical Center
Responsible Party
Principal Investigator
Principal Investigator

Dr. med. Martin Kimmel, MD

MD

Robert Bosch Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

Incidence of AKI in both groups according to AKI KDIGO definition

Time Frame: within 24 hours

Secondary Outcomes

  • 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)

Study Sites (1)

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