Prevention of Acute Kidney Injury Through Biomarker-guided Nephrological Intervention

Prevention of Acute Kidney Injury Through Biomarker-guided Nephrological

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.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Other: Early nephrologist 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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Stuttgart, Germany, 70376
    • Robert-Bosch Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard care; Patients with elevated biomarkers receive a standard treatment.
Active Comparator: Interventional care; Patients in the interventional population receive an early nephrologist consultation which deliberates with attending doctor on preventing measures according to AKI-KDIGO recommendations.	Other: Early nephrologist consultation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of AKI in both groups according to AKI KDIGO definition	within 24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Need for renal replacement therapy	within 24 hours
Need for renal replacement therapy	within 72 hours
Need for renal replacement therapy	within 30 days
Need for renal replacement therapy	within 60 days
Length of hospital stay	within 30 days
Length of hospital stay	within 60 days
Death	within 30 days
Death	within 60 days
Incidence of AKI in both groups according to AKI KDIGO definition	within 72 hours
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 30 days
Severity of AKI in both groups according to AKI KDIGO definition	within 30 days
Incidence of AKI in both groups according to AKI KDIGO definition	within 60 days
Severity of AKI in both groups according to AKI KDIGO definition	within 60 days

Collaborators and Investigators

• Sponsor: Robert Bosch Medical Center
• Investigators: Principal Investigator: Martin Kimmel, MD, Robert Bosch Gesellschaft für medizinische Forschung mbH; Principal Investigator: Mark Dominik Alscher, MD, Robert Bosch Gesellschaft für medizinische Forschung mbH

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: March 18, 2016
• First Submitted That Met QC Criteria: March 31, 2016
• First Posted (Estimate): April 6, 2016

Study Record Updates

• Last Update Posted (Actual): December 15, 2017
• Last Update Submitted That Met QC Criteria: December 14, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: RBK-348