Homburg Renal Evaluation Study on the Clinical Utility of Early AKI Diagnosis

Study Overview
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Brief Summary
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Critically ill patients are at risk of developing a sudden decrease of kidney function which may be detected by a decrease in urine output or is diagnosed on the basis of blood tests for substances normally eliminated by the kidney, primarily creatinine. Because it takes about 24 hours for the creatinine level to rise, even if both kidneys have ceased to function, better markers are needed. This trial is investigating if the marker urinary dickkopf-3 (uDKK3) allows an early prediction of a sudden decrease of kidney function.

Detailed Description
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Urinary dickkopf-3 (uDKK3), a stress-induced renal tubular epithelium-derived glycoprotein, has been identified as a biomarker predicting persistent kidney dysfunction. In this prospective observational trial in patients at high risk of developing acute kidney injury we will assess whether urinary dickkopf-3 serves as a predictor of acute kidney injury. Patients of the intensive care units of Saarland University Hospital will be surveyed for up to two years after their admission to the intensive care unit. The progression of the estimated Glomerular Filtration Rate and uDKK3 will be monitored.

Official Title
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Homburg Renal Evaluation Study on the Clinical Utility of Early AKI Diagnosis

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Diagnostic Test: DKK-3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients treated on the intensive care units of Saarland University Hospital. Exclusion Criteria: Patients on renal replacement treatment before admission to the intensive care unit. Patients with chronic kidney disease stage CKD G3b or below. Known kidney disease. Kidney transplantation. Intoxications leading to dialysis treatment. Participation in other clinical trials.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: DKK-3|DKK-3-Urine measurement|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary dickkopf-3 | Urinary dickkopf-3 | Throughout observational period, defined as timeframe from admission to intensive care unit up to two years after. | 
| Estimated Glomerula Filtration Rate | Estimated Glomerula Filtration Rate by CKD-EPI-formula. | Throughout observational period, defined as timeframe from admission to intensive care unit up to two years after. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Number of patients who die during the observational period. | Throughout observational period, defined as timeframe from admission to intensive care unit up to two years after. | 
| End Stage Renal Disease | Number of patients with initiation of chronic kidney replacement therapy (maintenance dialysis or kidney transplantation). | Throughout observational period, defined as timeframe from admission to intensive care unit up to two years after. | 
| Length of renal replacement therapy | Length of time patients receive renal replacement therapy for chronic kidney injury. | During the ICU stay. |