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

NCT ID: NCT06180551

Last Updated: 2023-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-01

Study Completion Date

2027-06-30

Brief Summary

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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

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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.

Conditions

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Acute Kidney Injury

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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DKK-3

DKK-3-Urine measurement

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universität des Saarlandes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefan Neuhaus, MD

Role: PRINCIPAL_INVESTIGATOR

Universität des Saarlandes

Locations

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Universitätsklinikum des Saarlandes

Homburg, Saarland, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Stefan Neuhaus, MD

Role: CONTACT

Phone: +4968411615041

Email: [email protected]

Facility Contacts

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Stefan Neuhaus, MD

Role: primary

Other Identifiers

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IMED IV-001

Identifier Type: -

Identifier Source: org_study_id