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NCT Number: NCT06180551

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

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum des Saarlandes

Homburg, Saarland, 66421, Germany

Location status: Recruiting

Location contact

Stefan Neuhaus, MD

CONTACT

[email protected]

+49684116 ext. 15041

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DKK-3

Diagnostic Test

DKK-3-Urine measurement

Primary outcomes

  1. Urinary dickkopf-3

    Time frame: Throughout observational period, defined as timeframe from admission to intensive care unit up to two years after.

    Urinary dickkopf-3

  2. Estimated Glomerula Filtration Rate

    Time frame: 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.

Secondary outcomes

  1. Mortality

    Time frame: 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.

  2. End Stage Renal Disease

    Time frame: 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).

  3. Length of renal replacement therapy

    Time frame: During the ICU stay.

    Length of time patients receive renal replacement therapy for chronic kidney injury.

Study contacts

Contact information is provided by the study sponsor or research team.

Stefan Neuhaus, MD

CONTACT

[email protected]

+4968411615041

Sponsors and collaborators

Lead sponsor

Universität des Saarlandes

Other

Registry information

Acronym: RESCUE-AKI

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Dec 22, 2023
Registry last updated
Dec 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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