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

Acute Kidney Injury Clinical Trial

— RESCUE-AKI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06180551
• Other study ID #: IMED IV-001
• Status: Recruiting
• Start date: December 1, 2023
• Est. completion date: June 2027

Study information

• Verified date: December 2023
• Source: Universität des Saarlandes
• Contact: Stefan Neuhaus, MD
• Phone: +4968411615041
• Email: stefan.neuhaus[@]uks.eu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 2027
• Est. primary completion date: December 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Diagnostic Test:
• DKK-3
DKK-3-Urine measurement

Locations

Country	Name	City	State
Germany	Universitätsklinikum des Saarlandes	Homburg	Saarland

Sponsors (1)

Lead Sponsor	Collaborator
Universität des Saarlandes

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary dickkopf-3	Urinary dickkopf-3	Throughout observational period, defined as timeframe from admission to intensive care unit up to two years after.
Primary	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	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.
Secondary	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.
Secondary	Length of renal replacement therapy	Length of time patients receive renal replacement therapy for chronic kidney injury.	During the ICU stay.