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

NCT06180551 | Recruiting

• 1 other identifier: IMED IV-001
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Mortality

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

• End Stage Renal Disease

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

• Length of renal replacement therapy

  During the ICU stay.

Interventions

DKK-3 DIAGNOSTIC_TEST

DKK-3-Urine measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients on intensive care units of the Saarland University Hospital.

You may qualify if:

• Patients treated on the intensive care units of Saarland University Hospital.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universität des Saarlandes: lead

Study Sites (1)

Universitätsklinikum des Saarlandes

Homburg, Saarland, 66421, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and urine samples.

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Stefan Neuhaus, MD

  Universität des Saarlandes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Neuhaus, MD

CONTACT

+4968411615041; stefan.neuhaus@uks.eu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 22, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)