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Prevention of Acute Kidney Injury Through Biomarker-guided Nephrological Intervention

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ClinicalTrials.gov Identifier: NCT02730637
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. med. Martin Kimmel, MD, Robert Bosch Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Other: Early nephrologist consultation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Acute Kidney Injury Through Biomarker-guided Nephrological
Study Start Date : March 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : November 2017

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Incidence of AKI in both groups according to AKI KDIGO definition [ Time Frame: within 24 hours ]

Secondary Outcome Measures :
  1. Need for renal replacement therapy [ Time Frame: within 24 hours ]
  2. Need for renal replacement therapy [ Time Frame: within 72 hours ]
  3. Need for renal replacement therapy [ Time Frame: within 30 days ]
  4. Need for renal replacement therapy [ Time Frame: within 60 days ]
  5. Length of hospital stay [ Time Frame: within 30 days ]
  6. Length of hospital stay [ Time Frame: within 60 days ]
  7. Death [ Time Frame: within 30 days ]
  8. Death [ Time Frame: within 60 days ]
  9. Incidence of AKI in both groups according to AKI KDIGO definition [ Time Frame: within 72 hours ]
  10. Severety of AKI in both groups according to AKI KDIGO definition [ Time Frame: within 72 hours ]
  11. Incidence of AKI in both groups according to AKI KDIGO definition [ Time Frame: within 30 days ]
  12. Severity of AKI in both groups according to AKI KDIGO definition [ Time Frame: within 30 days ]
  13. Incidence of AKI in both groups according to AKI KDIGO definition [ Time Frame: within 60 days ]
  14. Severity of AKI in both groups according to AKI KDIGO definition [ Time Frame: within 60 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02730637


Locations
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Germany
Robert-Bosch Hospital
Stuttgart, Germany, 70376
Sponsors and Collaborators
Robert Bosch Medical Center
Investigators
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Principal Investigator: Martin Kimmel, MD Robert Bosch Gesellschaft für Medizinische Forschung mbH
Principal Investigator: Mark Dominik Alscher, MD Robert Bosch Gesellschaft für Medizinische Forschung mbH

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. med. Martin Kimmel, MD, MD, Robert Bosch Medical Center
ClinicalTrials.gov Identifier: NCT02730637     History of Changes
Other Study ID Numbers: RBK-348
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
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Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases