Clinical trial NCT02730637: Prevention of Acute Kidney Injury Through Biomarker-guided Nephrological Intervention
Official title: Prevention of Acute Kidney Injury Through Biomarker-guided Nephrological
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Lead sponsor: Robert Bosch Medical Center
Sponsor class: OTHER
First posted: 2016-04-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence of AKI in both groups according to AKI KDIGO definition
timeFrame: within 24 hours
Secondary outcomes:
measure: Need for renal replacement therapy
timeFrame: within 24 hours
measure: Need for renal replacement therapy
timeFrame: within 72 hours
measure: Need for renal replacement therapy
timeFrame: within 30 days
measure: Need for renal replacement therapy
timeFrame: within 60 days
measure: Length of hospital stay
timeFrame: within 30 days
measure: Length of hospital stay
timeFrame: within 60 days
measure: Death
timeFrame: within 30 days
measure: Death
timeFrame: within 60 days
measure: Incidence of AKI in both groups according to AKI KDIGO definition
timeFrame: within 72 hours
measure: Severety of AKI in both groups according to AKI KDIGO definition
timeFrame: within 72 hours
measure: Incidence of AKI in both groups according to AKI KDIGO definition
timeFrame: within 30 days
measure: Severity of AKI in both groups according to AKI KDIGO definition
timeFrame: within 30 days
measure: Incidence of AKI in both groups according to AKI KDIGO definition
timeFrame: within 60 days
measure: Severity of AKI in both groups according to AKI KDIGO definition
timeFrame: within 60 days
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Robert-Bosch Hospital
Study officials:
affiliation: Robert Bosch Gesellschaft für Medizinische Forschung mbH
name: Martin Kimmel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Robert Bosch Gesellschaft für Medizinische Forschung mbH
name: Mark Dominik Alscher, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.