Trial document




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  DRKS00005062

Trial Description

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Title

Prospective observational study for the evaluation of new biomarkers in urine for acute kidney injury after cardiac surgery.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The kidney is the major excretory organ and responsible for the elemination of waste products by urine production. Cardiac surgery can affect the kidney function by acute renal injury. The aim of this trial is to investigate whether new biomarkers (e.g. hyaluronic acid and further new biomarkers) in urine can be utilized for the early detection of acute kidney injury in patients undergoing cardiac surgery. This clinical trial is neccessary to identify new biomarkers to detect acute renal failure early in the course of the disease and to improve therapeutic options and patient outcome.

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Brief Summary in Scientific Language

Acute kidney injury (AKI) is decrease in kidney function with sudden onset (hours to days), which is generally reversible.[1]
AKI can occur in previously healthy patients, but also following pre-existing chronic kidney disease. Acute kidney injury has different causes, including sepsis, hypovolemia, hypotension (shock), and medication toxicity.[1]
AKI causes disregulation of the homeostasis as well as retention of metabolic waste products (e.g. ureac) and other urine-excreted substances (e.g. creatinine) in the organism.
This may cause potentially life-threatening conditions.[1]
Acute kidney injury is a common complication following cardiac surgery and is associated with an increased morbidity and mortality.[2]
Cardiac surgery ranks among the three most frequent causes for in-hospital acute kidney injury.[2]
AKI ist classified with the use of various scoring systems (RIFLE, AKIN and KDIGO).[3, 4]
All scoring system rely on the measurement of urine production in a defined time period and/or measurement of serum creatinine levels. However, serum creatinine levels are unsuitable for the detection of a beginnig kidney injury but rather valid for the detection of already existing kidney injury, as the serum creatinine levels just begins to rise when the glomerular filtration rate is already severly decreased (decrease of the glomerular filtration rate to < 60ml/min., normal value: 120 ml/min.).[4] To date, there is no specific therapy for acute kidney injury. Available treatment option are only supportive measures and the avoidance of nephrotoxic substances.[5] As the available diagnostic tests only posses very limited sensitivity and specificity, risk stratification of acute kidney injury is very difficult.[6] To better understand the pathophysiology of acute kidney injury and for the developement of early treatment options, it is neccessary to identify new biomarker for the early detection of acute kidney injury, its etiology, and prediction of the severity of the disease. In the case of myocardial infarction, the introduction of troponin enabled an early diagnosis and ealier therapy. To date, no single biomarker for the early detection of acute kidney injury has been identified.
The aim of this trial is to investigate whether new biomarkers (e.g. hyaluronic acid and further new biomarkers) in urine can be utilized for the early detection of acute kidney injury in patients undergoing cardiac surgery. This clinical trial is neccessary to identify new biomarkers to detect acute renal failure early in the course of the disease and to improve therapeutic options and patient outcome.

References
1. Srisawat N, Kellum JA. Acute kidney injury: Definition, epidemiology, and outcome. Current opinion in critical care. 2011;17:548-555
2. Garwood S. Cardiac surgery-associated acute renal injury: New paradigms and innovative therapies. Journal of cardiothoracic and vascular anesthesia. 2010;24:990-1001
3. Bellomo R, Kellum JA, Ronco C. Acute kidney injury. Lancet. 2012;380:756-766
4. Haase M, Kellum JA, Ronco C. Subclinical aki--an emerging syndrome with important consequences. Nature reviews. Nephrology. 2012;8:735-739
5. Zarbock A, Singbartl K, Kellum JA. Evidence-based renal replacement therapy for acute kidney injury. Minerva anestesiologica. 2009;75:135-139
6. Siew ED, Ware LB, Ikizler TA. Biological markers of acute kidney injury. Journal of the American Society of Nephrology : JASN. 2011;22:810-820


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Organizational Data

  •   DRKS00005062
  •   2013/06/12
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  •   yes
  •   Approved
  •   2013-157-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

  •   U1111-1144-2118 
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Health Condition or Problem studied

  •   N17.9 -  Acute renal failure, unspecified
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Interventions/Observational Groups

  •   50 adult patients undergoing cardiac surgery with an increased risk for the developement of postoperative acute kidney injury (Cleveland-Score >9).

    The patients receive the perioperative standard treatment for the respective cardiac surgery procedure using the extracorporal circulation. Urine samples are obtained from the urine cathether (5 ml) for the evaluation of biomarker for the identificaion of acute kidney injury after induction of general anesthesia, and after 4h, 12h, 48h and 96h after the end of the surgical procedure. Additionaly, blood samples are obtained from an intravascular cathether as part of the standard therapy regimen for the measurement of serum creatinine and blood urea nitrogen levels.

    Measurement parameters:
    hyaluronic acid, KIM-1, NGAL, TIMP-2 (tissue inhibitor of metalloproteinases-2), IGFBP7 (insulin-like growth factor-binding protein 7), GDF-15, other biomarkers and creatinine.

    Clinical data:
    Cardio-respiratory variables
    Laboratory data
    Infectiological Monitoring
    Medication
    Demographic data
  •   50 children with congenital heart defects undergoing cardiac surgery.
    These patients receive the same treatment as the patients in the 1. study arm.
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Diagnostic
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

The primary outcome of this study is the measurement of the biomarker levels for the detection of acute kidney injury in the patients urine. Urine samples are obtained from the urine cathether (5 ml) for the evaluation of biomarker for the identificaion of acute kidney injury after induction of general anesthesia, and after 4h, 12h, 48h and 96h after the end of the surgical procedure. Additionaly, blood samples are obtained from an intravascular cathether as part of the standard therapy regimen for the measurement of serum creatinine and blood urea nitrogen levels.
The following parameter will be measured in urine samples:
Hyaluronic acid, KIM-1, NGAL, TIMP-2 (tissue inhibitor of metalloproteinases-2), IGFBP7 (insulin-like growth factor-binding protein 7), GDF-15, other biomarkers and creatinine.
The data in this study will be obtained and recorded using standardized data sheets.

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Secondary Outcome

The secondary outcome of this study is the evaluation of further clinical relevant variables affecting the patients course of the disease:
Cardio-pulmonary parameters
laboratory data
infectiological monitoring
medication
demographical data
The data in this study will be obtained and recorded using standardized data sheets.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2013/06/17
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

50 adult patients undergoing cardiac surgery with an increased risk for the developement of postoperative acute kidney injury (Cleveland-Score >9).
50 children with congenital heart defects undergoing cardiac surgery

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Exclusion Criteria

1. Pregnancy
2. Immunosuppressive Therapy (within the past 7 days)
3. Hematologcal Precondition
4. HIV infection
5. Acute oder chronic Inflammation
6. Previous organ transplantaion

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Addresses

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    • University Hospital Münster
    • Albert-Schweitzer-Campus 1
    • 48149  Münster
    • Germany
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    • Klinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie Universitätsklinikum Münster
    • Mr.  Prof.  Alexander  Zarbock 
    • Albert-Schweitzer-Campus 1, Gebäude A1
    • 48149  Münster
    • Germany
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    • Klinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie Universitätsklinikum Münster
    • Mr.  Prof.  Alexander  Zarbock 
    • Albert-Schweitzer-Campus 1, Gebäude A1
    • 48149  Münster
    • 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 planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.