Prevention of Acute Kidney Injury Through Biomarker-guided Nephrological Intervention

Acute Kidney Injury Clinical Trial

Official title:

Prevention of Acute Kidney Injury Through Biomarker-guided Nephrological

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02730637
• Other study ID #: RBK-348
• Status: Completed
• Phase: N/A
• First received: March 18, 2016
• Last updated: December 14, 2017
• Start date: March 2016
• Est. completion date: November 2017

Study information

• Verified date: December 2017
• Source: Robert Bosch Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

Other:
• Early nephrologist consultation

Locations

Country	Name	City	State
Germany	Robert-Bosch Hospital	Stuttgart

Sponsors (1)

Lead Sponsor	Collaborator
Robert Bosch Medical Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of AKI in both groups according to AKI KDIGO definition		within 24 hours
Secondary	Need for renal replacement therapy		within 24 hours
Secondary	Need for renal replacement therapy		within 72 hours
Secondary	Need for renal replacement therapy		within 30 days
Secondary	Need for renal replacement therapy		within 60 days
Secondary	Length of hospital stay		within 30 days
Secondary	Length of hospital stay		within 60 days
Secondary	Death		within 30 days
Secondary	Death		within 60 days
Secondary	Incidence of AKI in both groups according to AKI KDIGO definition		within 72 hours
Secondary	Severety of AKI in both groups according to AKI KDIGO definition		within 72 hours
Secondary	Incidence of AKI in both groups according to AKI KDIGO definition		within 30 days
Secondary	Severity of AKI in both groups according to AKI KDIGO definition		within 30 days
Secondary	Incidence of AKI in both groups according to AKI KDIGO definition		within 60 days
Secondary	Severity of AKI in both groups according to AKI KDIGO definition		within 60 days