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Prevention of Acute Kidney Injury Through Biomarker-guided Nephrological Intervention

Primary Purpose

Acute Kidney Injury

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Early nephrologist consultation
Sponsored by
Robert Bosch Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Kidney Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Robert-Bosch Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Standard care

Interventional care

Arm Description

Patients with elevated biomarkers receive a standard treatment.

Patients in the interventional population receive an early nephrologist consultation which deliberates with attending doctor on preventing measures according to AKI-KDIGO recommendations.

Outcomes

Primary Outcome Measures

Incidence of AKI in both groups according to AKI KDIGO definition

Secondary Outcome Measures

Need for renal replacement therapy
Need for renal replacement therapy
Need for renal replacement therapy
Need for renal replacement therapy
Length of hospital stay
Length of hospital stay
Death
Death
Incidence of AKI in both groups according to AKI KDIGO definition
Severety of AKI in both groups according to AKI KDIGO definition
Incidence of AKI in both groups according to AKI KDIGO definition
Severity of AKI in both groups according to AKI KDIGO definition
Incidence of AKI in both groups according to AKI KDIGO definition
Severity of AKI in both groups according to AKI KDIGO definition

Full Information

First Posted
March 18, 2016
Last Updated
December 14, 2017
Sponsor
Robert Bosch Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02730637
Brief Title
Prevention of Acute Kidney Injury Through Biomarker-guided Nephrological Intervention
Official Title
Prevention of Acute Kidney Injury Through Biomarker-guided Nephrological
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Robert Bosch Medical Center

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Patients with elevated biomarkers receive a standard treatment.
Arm Title
Interventional care
Arm Type
Active Comparator
Arm Description
Patients in the interventional population receive an early nephrologist consultation which deliberates with attending doctor on preventing measures according to AKI-KDIGO recommendations.
Intervention Type
Other
Intervention Name(s)
Early nephrologist consultation
Primary Outcome Measure Information:
Title
Incidence of AKI in both groups according to AKI KDIGO definition
Time Frame
within 24 hours
Secondary Outcome Measure Information:
Title
Need for renal replacement therapy
Time Frame
within 24 hours
Title
Need for renal replacement therapy
Time Frame
within 72 hours
Title
Need for renal replacement therapy
Time Frame
within 30 days
Title
Need for renal replacement therapy
Time Frame
within 60 days
Title
Length of hospital stay
Time Frame
within 30 days
Title
Length of hospital stay
Time Frame
within 60 days
Title
Death
Time Frame
within 30 days
Title
Death
Time Frame
within 60 days
Title
Incidence of AKI in both groups according to AKI KDIGO definition
Time Frame
within 72 hours
Title
Severety of AKI in both groups according to AKI KDIGO definition
Time Frame
within 72 hours
Title
Incidence of AKI in both groups according to AKI KDIGO definition
Time Frame
within 30 days
Title
Severity of AKI in both groups according to AKI KDIGO definition
Time Frame
within 30 days
Title
Incidence of AKI in both groups according to AKI KDIGO definition
Time Frame
within 60 days
Title
Severity of AKI in both groups according to AKI KDIGO definition
Time Frame
within 60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Kimmel, MD
Organizational Affiliation
Robert Bosch Gesellschaft für Medizinische Forschung mbH
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Dominik Alscher, MD
Organizational Affiliation
Robert Bosch Gesellschaft für Medizinische Forschung mbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert-Bosch Hospital
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
29961888
Citation
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.
Results Reference
derived

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Prevention of Acute Kidney Injury Through Biomarker-guided Nephrological Intervention

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