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NCT Number: NCT02730637

Prevention of Acute Kidney Injury Through Biomarker-guided Nephrological Intervention

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Robert-Bosch Hospital

Stuttgart, 70376, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early nephrologist consultation

Other

Primary outcomes

  1. Incidence of AKI in both groups according to AKI KDIGO definition

    Time frame: within 24 hours

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Robert Bosch Medical Center

Other

Registry information

Official study title

Prevention of Acute Kidney Injury Through Biomarker-guided Nephrological

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 6, 2016
Registry last updated
Dec 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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