Clinical trial NCT06180551: Homburg Renal Evaluation Study on the Clinical Utility of Early AKI Diagnosis
Official title: Homburg Renal Evaluation Study on the Clinical Utility of Early AKI Diagnosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Kidney Injury
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
First posted: 2023-12-22
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients on intensive care units of the Saarland University Hospital.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Urinary dickkopf-3
timeFrame: Throughout observational period, defined as timeframe from admission to intensive care unit up to two years after.
measure: Estimated Glomerula Filtration Rate
timeFrame: Throughout observational period, defined as timeframe from admission to intensive care unit up to two years after.
Secondary outcomes:
measure: Mortality
timeFrame: Throughout observational period, defined as timeframe from admission to intensive care unit up to two years after.
measure: End Stage Renal Disease
timeFrame: Throughout observational period, defined as timeframe from admission to intensive care unit up to two years after.
measure: Length of renal replacement therapy
timeFrame: During the ICU stay.
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes
state: Saarland
Study officials:
affiliation: Universität des Saarlandes
name: Stefan Neuhaus, MD
role: PRINCIPAL_INVESTIGATOR
References: