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

Recruiting

• Conditions: Acute Kidney Injury

• Registration Number: NCT06180551
• Lead Sponsor: Universität des Saarlandes

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.

Study Timeline

• Status Verified: 2023-12
• Study Start: 2023-12-01
• Study First Submitted: 2023-12-12
• Study First Submitted QC: 2023-12-12
• Last Update Submitted: 2023-12-12
• Study First Posted: 2023-12-22
• Last Update Posted: 2023-12-22
• Primary Completion: 2026-12
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Universitätsklinikum des Saarlandes; 🇩🇪 Homburg, Saarland, Germany