Acute Kidney InjuryNCT02730637
Prevention of Acute Kidney Injury Through Biomarker-guided Nephrological Intervention
A study testing Early nephrologist consultation in people with Acute Kidney Injury, run by Robert Bosch Medical Center at 1 site in Germany.
Trial summary
This study examines the clinical relevance of early biomarkers to detect and prevent acute kidney injury. High-risk patients for developing acute kidney injury will be screened at initial presentation (emergency department and intensive care unit) for TIMP2xIGFBP7. 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?
- Early nephrologist consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2016to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- no acute kidney injury stage II-III (according to AKI KDIGO definition)
- urinary biomarker levels above cut-off
- inpatient treatment
- age ≥18 years
- informed consent or presumed will
Who cannot join
- existing acute kidney injury stage II-III (according to AKI KDIGO definition)
- age < 18 years
- end stage renal disease (ESRD), existing renal replacement therapy
- pregnancy
- withdrawal of consent
- missing presumed will
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Acute Kidney Injury Through Biomarker-guided Nephrological
This study examines the clinical relevance of early biomarkers to detect and prevent acute kidney injury. High-risk patients for developing acute kidney injury will be screened at initial presentation (emergency department and intensive care unit) for TIMP2xIGFBP7. In case of elevated readings patients will be randomized in two arms: The control group will be treated with standard care, the intervention group will receive an early nephrologic consultation.
Read the detailed description
This study examines the impact of an early biomarker-guided intervention on the development of acute kidney injury (AKI). New biomarkers indicate kidney damage in an early stage before developing acute kidney injury according to AKI Kidney Disease Improving Global Outcomes (KDIGO) Definition is detectable. The investigators want to test if it's possible to prevent AKI based on elevated urinary biomarkers. Eligible patients will be randomly assigned to two groups, a control and an intervention Group by an early nephrologic consultation. The interventional group will receive an early preventive nephrologist consultation additionally to standard care.
- Conditions
- Acute Kidney Injury
- Being tested
- Early nephrologist consultation
- 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.
Early nephrologist consultationOther
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | Patients with elevated biomarkers receive a standard treatment. |
| Interventional care | Active comparator | Patients in the interventional population receive an early nephrologist consultation which deliberates with attending doctor on preventing measures according to AKI-KDIGO recommendations. Receives: Other: Early nephrologist consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AKI in both groups according to AKI KDIGO definition
Measured: within 24 hours
Secondary outcomes (14)
Need for renal replacement therapy
Measured: within 24 hours
Need for renal replacement therapy
Measured: within 72 hours
Need for renal replacement therapy
Measured: within 30 days
Need for renal replacement therapy
Measured: within 60 days
Length of hospital stay
Measured: within 30 days
Length of hospital stay
Measured: within 60 days
Death
Measured: within 30 days
Death
Measured: within 60 days
Incidence of AKI in both groups according to AKI KDIGO definition
Measured: within 72 hours
Severety of AKI in both groups according to AKI KDIGO definition
Measured: within 72 hours
Incidence of AKI in both groups according to AKI KDIGO definition
Measured: within 30 days
Severity of AKI in both groups according to AKI KDIGO definition
Measured: within 30 days
Incidence of AKI in both groups according to AKI KDIGO definition
Measured: within 60 days
Severity of AKI in both groups according to AKI KDIGO definition
Measured: within 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionOct 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Bosch Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Martin Kimmel, MD, Robert Bosch Medical Center
- Investigators
- Martin Kimmel, MD, Principal investigator, Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)Mark Dominik Alscher, MD, Principal investigator, Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730637
- Sponsor's protocol ID
- RBK-348
- Status last verified
- Dec 2017
- First submitted
- 18 Mar 2016
- Last updated
- 15 Dec 2017
- Results posted
- No
Publications
Schanz M, Wasser C, Allgaeuer S, Schricker S, Dippon J, Alscher MD, Kimmel M. Urinary [TIMP-2].[IGFBP7]-guided randomized controlled intervention trial to prevent acute kidney injury in the emergency department. Nephrol Dial Transplant. 2019 Nov 1;34(11):1902-1909. doi: 10.1093/ndt/gfy186.
PubMed 29961888
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Acute Kidney Injury Through Biomarker-guided Nephrological
- ClinicalTrials.gov ID
- NCT02730637
- Acronym / sponsor ID
- RBK-348
- Conditions
- Acute Kidney Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Robert Bosch Medical CenterUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Oct 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 6 Apr 2016 (estimated)
- 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.
This study examines the clinical relevance of early biomarkers to detect and prevent acute kidney injury. High-risk patients for developing acute kidney injury will be screened at initial presentation (emergency department and intensive care unit) for TIMP2xIGFBP7. In case of elevated readings patients will be randomized in two arms: The control group will be treated with standard care, the intervention group will receive an early nephrologic consultation.
Detailed description
This study examines the impact of an early biomarker-guided intervention on the development of acute kidney injury (AKI). New biomarkers indicate kidney damage in an early stage before developing acute kidney injury according to AKI Kidney Disease Improving Global Outcomes (KDIGO) Definition is detectable. The investigators want to test if it's possible to prevent AKI based on elevated urinary biomarkers. Eligible patients will be randomly assigned to two groups, a control and an intervention Group by an early nephrologic consultation. The interventional group will receive an early preventive nephrologist consultation additionally to standard care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –Patients with elevated biomarkers receive a standard treatment. |
| Interventional care | Active comparator | Other: Early nephrologist consultationPatients in the interventional population receive an early nephrologist consultation which deliberates with attending doctor on preventing measures according to AKI-KDIGO recommendations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- no acute kidney injury stage II-III (according to AKI KDIGO definition)
- urinary biomarker levels above cut-off
- inpatient treatment
- age ≥18 years
- informed consent or presumed will
Key exclusion criteria (6 listed)
- existing acute kidney injury stage II-III (according to AKI KDIGO definition)
- age < 18 years
- end stage renal disease (ESRD), existing renal replacement therapy
- pregnancy
- withdrawal of consent
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 |
|---|---|---|
| Early nephrologist consultation | Other | Interventional care |
Primary outcome
Incidence of AKI in both groups according to AKI KDIGO definition
Time frame: within 24 hours
14 secondary outcomes
Need for renal replacement therapy
Time frame: within 24 hours
Need for renal replacement therapy
Time frame: within 72 hours
Need for renal replacement therapy
Time frame: within 30 days
Need for renal replacement therapy
Time frame: within 60 days
Length of hospital stay
Time frame: within 30 days
Length of hospital stay
Time frame: within 60 days
Death
Time frame: within 30 days
Death
Time frame: within 60 days
Incidence of AKI in both groups according to AKI KDIGO definition
Time frame: within 72 hours
Severety of AKI in both groups according to AKI KDIGO definition
Time frame: within 72 hours
Incidence of AKI in both groups according to AKI KDIGO definition
Time frame: within 30 days
Severity of AKI in both groups according to AKI KDIGO definition
Time frame: within 30 days
Incidence of AKI in both groups according to AKI KDIGO definition
Time frame: within 60 days
Severity of AKI in both groups according to AKI KDIGO definition
Time frame: within 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2017.
- Derived from this study: PubMed 29961888Schanz M, Wasser C, Allgaeuer S, Schricker S, Dippon J, Alscher MD, Kimmel M. Urinary [TIMP-2].[IGFBP7]-guided randomized controlled intervention trial to prevent acute kidney injury in the emergency department. Nephrol Dial Transplant. 2019 Nov 1;34(11):1902-1909. doi: 10.1093/ndt/gfy186.
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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. This study is not recruiting at the moment.
Martin Kimmel, MD principal investigator
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
Mark Dominik Alscher, MD principal investigator
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early nephrologist consultation in people with Acute Kidney Injury, run by Robert Bosch Medical Center 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 5 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: finished, as of the sponsor's last update on 15 Dec 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AKI in both groups according to AKI KDIGO definition (time frame: within 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02730637, which also lists 1 linked publication.
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 15 Dec 2017.