CompletedNCT02730637Updated Dec 15, 2017

Prevention of Acute Kidney Injury Through Biomarker-guided Nephrological Intervention

An interventional study of Early nephrologist consultation in Acute Kidney Injury, sponsored by Robert Bosch Medical Center. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-15.

Sponsored by Robert Bosch Medical Center · Not applicable, Interventional, and Prevention

Phase: Not applicable
Study type: Interventional
Enrollment: 100
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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. 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 studied

Acute Kidney Injury

Browse trials for

Acute Kidney Injury 1,641

In context

Acute Kidney Injury

1,641 studies on the registry are indexed under Acute Kidney Injury; 380 are open to participants now.

This study's enrollment of 100 is close to the median of 100 across 786 interventional studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Robert Bosch Medical Center is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 100 participants (actual)

Study arms

No intervention
Standard care
Patients with elevated biomarkers receive a standard treatment.
Active comparator
Interventional care
Patients in the interventional population receive an early nephrologist consultation which deliberates with attending doctor on preventing measures according to AKI-KDIGO recommendations.
Other: Early nephrologist consultation

Interventions

OtherEarly nephrologist consultation

What researchers measure

Primary outcomes

Incidence of AKI in both groups according to AKI KDIGO definition
Time frame: within 24 hours

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

Study locations

1 site

Robert-Bosch Hospital
Stuttgart, 70376, Germany

References and documents

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 ↗

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2016, a primary completion of Oct 2017 and a completion of Nov 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 18, 2016
First posted: Apr 6, 2016
Start: Mar 2016
Primary completionActual: Oct 2017
CompletionActual: Nov 2017
Last update: Dec 15, 2017

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Dec 15, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02730637
Lead sponsor: Robert Bosch Medical Center
Responsible party: Dr. med. Martin Kimmel, MD (MD, Robert Bosch Medical Center) — Principal investigator
First posted: Apr 6, 2016
Start date: Mar 2016
Primary completion: Oct 2017
Completion: Nov 2017
Last update: Dec 15, 2017

Study contacts

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)

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Acute Kidney Injury →

Other studies from this sponsor

Robert Bosch Medical Center

Start the discussion