Trial document





This trial has been registered retrospectively.
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  DRKS00007616

Trial Description

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Title

Influence of risk factors and prevention with sodium bicarbonate on the incidence of acute kidney injury after cardiac surgery

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Trial Acronym

AKI risk factors

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Propspective observational trial of the influence of pre- and intraoperative risk factors and sodium bicarbonate iv infusion on the incidence of AKI after on-pump cardiac surgery.

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Brief Summary in Scientific Language

The data of this study resulted from a large observational trial of pre- and intraoperative risk factors of AKI after cardiac surgery. Iinfluence of sodium bicarbonate iv infusion on the incidence of AKI after on-pump cardiac surgery.

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Organizational Data

  •   DRKS00007616
  •   2014/12/12
  •   [---]*
  •   yes
  •   Approved
  •   21/6/09, Ethik-Kommission der Medizinischen Fakultät der Georg-August-Universität Göttingen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   N17 -  Acute renal failure
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Interventions/Observational Groups

  •   Patient without acute kidney injury.
    Determination of preoperartive risik factors of AKI accodring to Thakar et al. (2005) and intraoperative factors: CPB-time, aortic cross clamping time, free hemoglobin, blood transfusion, sodium bicarbonate iv infusion (according to standard operation procedure of the deparment 8,4% iv 0,15mmol/kg/BW/h, start after induction of anesthesia until 2 p.m. of the first postoperative day). Postoperative Evaluation of AKI according to AKIN-criteria.
  •   patients with acute kidney injury.
    Determination of preoperartive risik factors of AKI accodring to Thakar et al. (2005) and intraoperative factors: CPB-time, aortic cross clamping time, free hemoglobin, blood transfusion, sodium bicarbonate iv infusion (according to standard operation procedure of the deparment (8,4% iv 0,15mmol/kg/BW/h, start after induction of anesthesia until 2 p.m. of the first postoperative day). Postoperative Evaluation of AKI according to AKIN-criteria
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Prevention
  •   Other
  •   N/A
  •   No
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Primary Outcome

AKI defined according to AKIN-Criteria

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Secondary Outcome

length of stay, in-hospital mortality

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2009/08/25
  •   1000
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

on-pump cardiac surgery

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Exclusion Criteria

preoperative renal replacement therapy

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Addresses

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    • Universitätsmedizin Göttingen
    • Robert-Koch-Straße 40
    • 37099  Göttingen
    • Germany
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    • Universitätsmedizin Göttingen
    • Ms.  Dr.  Anna  Wetz 
    • Robert-Kochstraße 40
    • 37075  Göttingen
    • Germany
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    • Universitätsmedizin Göttingen
    • Ms.  Dr.  Anna  Wetz 
    • Robert-Kochstraße 40
    • 37075  Göttingen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsmedizin Göttingen
    • Robert-Koch-Straße 40
    • 37099  Göttingen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/04/01
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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.