Trial document




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  DRKS00008778

Trial Description

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Title

Extended hemodynamical monitoring using an esophageal doppler probe during cemented hip arthroplasty to analyze postoperative complications.

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Trial Acronym

esophageal doppler probe DOT

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URL of the Trial

http://Keine

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Brief Summary in Lay Language

In this prospective, randomized clinical trial, patients are included, who will receive a cemented hip arthroplasty. After randomization into one of two groups, every patient will receive an intraesophageal doppler probe to measure and analyze aortic blood flow and resulting cardiac parameters (i.e. stroke volume, cardiac index etc). Esophageal probe data of patients in the control group will only be recorded while the anesthesist is blind for these. Data of the patients in the intervention group will be shown to the anesthesist on side, who will interpret data and react as recommended in the clinical pathways. Primary endpoint: Perioperative changes in hemodynamics (a) before (b) during and (c) after the insertion of palacos in the bone. Secondary endpoint: incidence of postoperative pulmonary complications and postoperative renal complications and alterations in cytokine profile of the peripheral blood as well as trouble with wound healing.

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Brief Summary in Scientific Language

Recording and analysis of cardiac parameters using an esophageal doppler probe

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Organizational Data

  •   DRKS00008778
  •   2015/06/16
  •   [---]*
  •   yes
  •   Approved
  •   160/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1171-2152 
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Health Condition or Problem studied

  •   S72.0 -  Fracture of neck of femur
  •   J84 -  Other interstitial pulmonary diseases
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Interventions/Observational Groups

  •   Patients of the control group undergoing hip surgery will receive the doppler probe after randomization. Resulting data will be recorded but not shown to the anesthesist on side. Possbile intraoperative correction of hemodynamics will be made using routine clinical data and settings.
  •   Patients in the intervention group undergoing hip surgery will receive the doppler probe after randomisation, too. In contrast, data will not only be recorded but shown to the anesthesist on side. Taking this additional data into account, the anesthesist may judge hemodynamics more precisely.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist, assessor, data analyst
  •   Active control (effective treament of control group)
  •   Diagnostic
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Perioperative changes in hemodynamics measured with the esophageal doppler probe (a) before (b) during and (c) after the insertion of palacos in the bone.

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Secondary Outcome

Recording and analysis of pulmonary complications (a) after 24 hours and (b) after 72 hours

Recording and analysis of postoperative renal complications, cytokine status and trouble with wound healing (a) after 24 hours and (b) after 72 hours.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/09/01
  •   90
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

- patients 18 years of age or above
- informed written consent
- operation for cemented hip arthroplasty in general anesthesia with endotracheal intubation and ventilation

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Exclusion Criteria

- denial for participation
- body mass index >50
- pathologies of the esophagus or the stomach
- pregnancy

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Anästhesiologische Universitätsklinik
    • Mr.  Prof. Dr.  Ulrich  Göbel 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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    • Anästhesiologische Universitätsklinik
    • Mr.  Prof. Dr.  Ulrich  Göbel 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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    • Anästhesiologische Universitätsklinik
    • Mr.  Prof. Dr.  Ulrich  Göbel 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Anästhesiologie und IntensivmedizinUniversitätsklinikum Freiburg
    • Mr.  Prof. Dr. med.  Ulrich  Göbel 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/10/31
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* This entry means the parameter is not applicable or has not been set.