Homburg Renal Evaluation Study on the Clinical Utility of... | NCT06180551

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

NCT06180551

Sponsor

Universität des Saarlandes

Status

Recruiting

Last Update Posted

Dec 22, 2023Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Acute Kidney Injury

Interventions

DKK-3

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2023Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Jun 2027Estimated

First Submitted Date

Dec 12, 2023

First Submission Date that Met QC Criteria

Dec 12, 2023

First Posted Date

Dec 22, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2023

Last Update Posted Date

Dec 22, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DKK-3	Diagnostic Test	DKK-3-Urine measurement

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients on intensive care units of the Saarland University Hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Stefan Neuhaus, MD	Contact	+4968411615041		stefan.neuhaus@uks.eu

Overall Officials

Name	Affiliation	Role
Stefan Neuhaus, MD	Universität des Saarlandes	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsklinikum des Saarlandes	Recruiting	Homburg	Saarland	66421	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

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