Trial document




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  DRKS00005416

Trial Description

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Title

Diagnostic use of calprotectin to prevent contrast media induced acute kidney injury

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In previous research we have identified for the first time calprotectin as a promising biomarker of acute renal failure . In the present project we will investigate whether the diagnostic use of calprotectin leads to prevention of a contrast induced acute kidney injury.
Patients with a glomerular filtration rate (GFR ) ≥ 60 ml / min, who, according to conventional standards, are not at increased risk for the development of contrast induced acute kidney injury, give an urinary sample prior to a planned coronary angiography.
The aim of the first phase of the study is to identify patients who have an increased risk for the development of contrast induced acute kidney injury. In the second phase of the study , patients at icreased risk undertake a nephroprotection by 1l isotonic saline iv before and after the application of contrast media. Creatinin will be assessed at baseline and after 48 hours. The diagnostic use of calprotectin leads to a prevention of contrast induced acute kidney injury.

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Brief Summary in Scientific Language

In previous research we have identified for the first time calprotectin ( S100A8/S100A9 ) as a promising biomarker in acute kidney injury. This molecule sensitively detects intrinsic kidney injury (Heller et al, CJASN 6:2347-2355, 2011; Seibert et al, Acta Physiol (Oxf ) 207:700-708, 2013). In the present project it will be investigated whether the diagnostic use of calprotectin to identify an increased risk for contrast induced acute kidney injury (CI-AKI) allows nephroprotective strategies and leads to an improvement in clinical endpoints.
Patients with a glomerular filtration rate (GFR ) ≥ 60 ml / min, who, according to conventional standards, are not at increased risk for the development of contrast induced acute kidney injury, give an urinary sample prior to a planned coronary angiography.
The study is planned in two phases. In the first study period, urine samples from patients undergoing cardiac catheter examination will be analyzed for calprotectin retrospectively. If the basic hypothesis that increased concentrations predict a higher risk of CI-AKI is confirmed in the first study period, the second study period will be started. Those patients with increased risk of CI-AKI (calprotectin > 100 ng/ml) receive the clinical standard of nephroprotection recommended by KDIGO guidelines (1l of isotonic saline before and after application of contrast media). The infusion of saline before and after application of contrast media leads to a reduction of the incidence of CI-AKI.

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Organizational Data

  •   DRKS00005416
  •   2013/11/08
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  •   yes
  •   Approved
  •   EA4/117/13, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  •   U1111-1149-7324 
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Health Condition or Problem studied

  •   N17 -  Acute renal failure
  •   N99.0 -  Postprocedural renal failure
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Interventions/Observational Groups

  •   Phase I of the study: Assessment of urinary concentration of calprotectin to identify patients at increased risk for contrast induced acute kidney injury.
  •   Phase II of the study: Administration of 1 liter of isotonic saline before and after administration of contrast medium to prevent contrast induced acute kidney injury. The intervention receive patients with increased risk for CI-AKI (Calprotectin >100ng/ml).
  •   Phase II of the staudy: Patients without a high risk of a CI-AKI (Calprotectin <100ng/ml) receive no intervention and are recruited in the control group.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Prevention
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Incidence of contrast induced acute kidney injury - assessment of renal function by serum creatinine

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Secondary Outcome

Proteinuria, dip-stick urinary examination

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/04/01
  •   894
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Anticipated cardiac catheter examination

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Exclusion Criteria

Anuria, age < 18 years, participation in another study, patients unable to give informed consent, eGFR < 60 ml/min per 1.73m2, pyuria, urothelial carcinoma, metastatic cancer , coronary angiography in acute myocardial infarction, congestive heart failure NYHA III-IV

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Addresses

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    • Medizinische Klinik I, Universitätsklinik Marienhospital Herne
    • Mr.  PD Dr. med.  Timm  Westhoff 
    • Hölkeskampring 40
    • 44625  Herne
    • Germany
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    • Klinik für Nephrologie, Charité, Universitätsmedizin Berlin
    • Mr.  PD Dr. med.  Thiemo  Pfab 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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    • Medizinische Klinik I, Universitätsklinik Marienhospital Herne
    • Mr.  PD Dr. med.  Timm  Westhoff 
    • Hölkeskampring 40
    • 44625  Herne
    • Germany
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    • Medizinische Klinik I, Universitätsklinik Marienhospital Herne
    • Mr.  Dr. med.  Nikolaos  Pagonas 
    • Hölkeskampring 40
    • 44625  Herne
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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