Trial document





This trial has been registered retrospectively.
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  DRKS00011093

Trial Description

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Title

Influence the composition of the primingvolume of cardiopulmonary bypass on perioperative fluid balance adult cardiac surgical patients.

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Trial Acronym

HESHLM

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The study examines the fluid balance in two groups of patients who have undergone cardiac surgery . The two study groups differ in the various filling composition of cardiopulmonary bypass. It will be investigated whether this has an effect on the fluid balance of the patient and the outcome of the Operation.

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Brief Summary in Scientific Language

This study, based on a retrospective data analysis, clarifies the question whether the addition of a colloidal volume replacement (hydroxyethyl starch 130 / 0.4) for priming of cardiopulmonary bypass in cardiac surgical patients has an impact on perioperative fluid balance. To prove this the balance sheets of all patients who have been treated with pure crystalloid priming volume, will be compared with those who contained an additive in the form of HES 130 / 0.4 of 500ml. It is scientifically proven that positive liquid balance sheets aggravate the clinical outcome in surgical patients , so there is an intensive search for therapeutic strategies. This study aims to show whether a colloidal primingvolume affects the fluid balance positive .

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Organizational Data

  •   DRKS00011093
  •   2017/05/12
  •   [---]*
  •   yes
  •   Approved
  •   2015-505-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

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

  •   Cardiac surgery using the CPB
  •   I20-I25 -  Ischaemic heart diseases
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Interventions/Observational Groups

  •   Priming of the cardiopulmonary bypass with pure cristalloid fluid.
  •   Priming of the cardiopulmonary bypass with an additive of colloid fluid in form of HES.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

Perioperative liquid balance from induction of the anaesthesia until 48 hours postoperative.

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Secondary Outcome

Infusion volume , blood loss , transfusion volume , urine volume , creatinine , creatinine clearance , lactate , cardiac enzymes , time to extubation , stay on ICU

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/09/14
  •   1120
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   89   Years
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Additional Inclusion Criteria

Cardiac surgery by using cardiopulmonary bypass using cristalloid fluid (study group 1: 03.09.2014 to 26.02.2015) and colloid fluid (study group 2: 27.02.2015 to 30.08.2015)

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Exclusion Criteria

incomplete data

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Addresses

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    • Universitätsklinikum MünsterKlinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie
    • Albert-Schweitzer-Campus 1, A1
    • 48149  Münster
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Universitätsklinikum MünsterKlinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie
    • Mr.  Priv.-Doz. Dr. med  Christoph  Schmidt 
    • Albert-Schweitzer-Campus 1, A1
    • 48149  Münster
    • Germany
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    • Universitätsklinikum MünsterKlinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie
    • Mr.  Priv.-Doz. Dr. med  Christoph  Schmidt 
    • Albert-Schweitzer-Campus 1, A1
    • 48149  Münster
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum MünsterKlinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie
    • Mr.  Priv.-Doz. Dr. med  Christoph  Schmidt 
    • Albert-Schweitzer-Campus 1, A1
    • 48149  Münster
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/12/22
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Trial Publications, Results and other Documents

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