Homburg Renal Evaluation Study on the Clinical Utility of Early AKI Diagnosis (RESCUE-AKI)

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Diagnostic test: DKK-3

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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Stefan Neuhaus, MD; Phone Number: +4968411615041; Email: stefan.neuhaus@uks.eu

Study Locations

• Germany
  • Saarland
    • Homburg, Saarland, Germany, 66421
      • Recruiting
      • Universitätsklinikum des Saarlandes
      • Contact: Stefan Neuhaus, MD; Phone Number: 15041 +49684116; Email: stefan.neuhaus@uks.eu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients on intensive care units of the Saarland University Hospital.

Description

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 Plan

How is the study designed?

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Universität des Saarlandes
• Investigators: Principal Investigator: Stefan Neuhaus, MD, Universität des Saarlandes

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: December 12, 2023
• First Submitted That Met QC Criteria: December 12, 2023
• First Posted (Actual): December 22, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Acute Kidney Injury
• Other Study ID Numbers: IMED IV-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No