Acute Kidney InjuryRESCUE-AKINCT06180551
Homburg Renal Evaluation Study on the Clinical Utility of Early AKI Diagnosis
An observational study of Acute Kidney Injury, run by Universität des Saarlandes at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- DKK-3
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2023to Jun 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients on intensive care units of the Saarland University Hospital.
Who may be able to join
- Patients treated on the intensive care units of Saarland University Hospital.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum des Saarlandes
Homburg, Saarland, 66421
Stefan Neuhaus, MD, +49684116 ext. 15041, stefan.neuhaus@uks.eu
About this study
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.
Read the 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.
- Conditions
- Acute Kidney Injury
- Being tested
- DKK-3
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DKK-3Diagnostic test
DKK-3-Urine measurement
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary dickkopf-3
Urinary dickkopf-3
Measured: 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.
Measured: Throughout observational period, defined as timeframe from admission to intensive care unit up to two years after.
Secondary outcomes (3)
Mortality
Number of patients who die during the observational period.
Measured: Throughout observational period, defined as timeframe from admission to intensive care unit up to two years after.
End Stage Renal Disease
Number of patients with initiation of chronic kidney replacement therapy (maintenance dialysis or kidney transplantation).
Measured: Throughout observational period, defined as timeframe from admission to intensive care unit up to two years after.
Length of renal replacement therapy
Length of time patients receive renal replacement therapy for chronic kidney injury.
Measured: During the ICU stay.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start1 Dec 2023
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Neuhaus, MD, Principal investigator, Universität des Saarlandes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180551
- Sponsor's protocol ID
- IMED IV-001
- Acronym
- RESCUE-AKI
- Status last verified
- Dec 2023
- First submitted
- 12 Dec 2023
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Homburg Renal Evaluation Study on the Clinical Utility of Early AKI Diagnosis
- ClinicalTrials.gov ID
- NCT06180551
- Acronym / sponsor ID
- RESCUE-AKI / IMED IV-001
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 22 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients on intensive care units of the Saarland University Hospital.
Key inclusion criteria (1 listed)
- Patients treated on the intensive care units of Saarland University Hospital.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DKK-3DKK-3-Urine measurement | Diagnostic test | – |
Primary outcome
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
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.
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury
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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
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Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
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Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
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WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefan Neuhaus, MD principal investigator
Universität des Saarlandes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Universität des Saarlandes at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefan Neuhaus, MD (+4968411615041, stefan.neuhaus@uks.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary dickkopf-3 (time frame: Throughout observational period, defined as timeframe from admission to intensive care unit up to two years after.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023; AzTrials last refreshed its copy on 8 Nov 2026.