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Recruiting NCT06180551

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

Observational Acute Kidney Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DKK-3.
Who it may be relevant to
Registry conditions: Acute Kidney Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Diagnostic test DKK-3
    DKK-3-Urine measurement

Primary outcome measures

  • Urinary dickkopf-3 [Time frame: Throughout observational period, defined as timeframe from admission to intensive care unit up to two years after.]
  • Estimated Glomerula Filtration Rate [Time frame: Throughout observational period, defined as timeframe from admission to intensive care unit up to two years after.]
Secondary outcome measures (3)
  • Mortality [Time frame: Throughout observational period, defined as timeframe from admission to intensive care unit up to two years after.]
  • End Stage Renal Disease [Time frame: Throughout observational period, defined as timeframe from admission to intensive care unit up to two years after.]
  • Length of renal replacement therapy [Time frame: During the ICU stay.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-only

Study locations

Germany · 1 center
  • Universitätsklinikum des Saarlandes — Homburg

Identifiers

NCT: NCT06180551 · IMED IV-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗