Prevention of Acute Kidney Injury Through Biomarker-guided Nephrological Intervention

Study 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.

Official Title
-----------------
Prevention of Acute Kidney Injury Through Biomarker-guided Nephrological

Conditions
-----------------
Acute Kidney Injury

Intervention / Treatment
-----------------
* Other: Early nephrologist consultation


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard care<br>Patients with elevated biomarkers receive a standard treatment. | |
| Active Comparator: Interventional care<br>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<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |