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Prevention of Acute Kidney Injury Through Biomarker-guided Nephrological Intervention

NCT ID: NCT02730637

Last Updated: 2017-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-11-30

Brief Summary

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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

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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

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard care

Patients with elevated biomarkers receive a standard treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Early nephrologist consultation

Intervention Type OTHER

Interventions

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Early nephrologist consultation

Intervention Type OTHER

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Robert Bosch Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Dr. med. Martin Kimmel, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martin Kimmel, MD

Role: PRINCIPAL_INVESTIGATOR

Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

Mark Dominik Alscher, MD

Role: PRINCIPAL_INVESTIGATOR

Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

Locations

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Robert-Bosch Hospital

Stuttgart, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 29961888 (View on PubMed)

Other Identifiers

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RBK-348

Identifier Type: -

Identifier Source: org_study_id