Trial document




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  DRKS00005472

Trial Description

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Title

Prospective observational study for non-invasive brachial artery reactivity testing as a prognostic factor of postoperative complications

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Cardiovascular diseases are common complications in non-cardiosurgical operations. In patients planned for surgery, preoperative ultrasonography of the brachial artery and an exercise test will be performed. Patients planned for surgery with opening the abdominal or thoracic cavity will be included in the study. We will investigate, if changes of the vascular reactivity correlate with postoperative complication rates.

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Brief Summary in Scientific Language

In our observational study, we will perform ultrasonography of the brachial artery. For validation of the exercise capacity, a stair climbing test will be arranged. Patients will be recruited during our preoperative anaesthesiologic visit. Patients planned for surgery with opening the abdominal or thoracic cavity will be included. We will investigate, if changes of the vascular reactivity predicts postoperative complication rates. Primary endpoint is the incidence of postoperative complications correlating with the reactivity of the brachial artery. Secondary endpoints comprise the correlation of the brachial artery reactivity with preoperative risk factors.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005472
  •   2013/11/25
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  •   yes
  •   Approved
  •   13-112, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   Postoperative cardiopulmonary complications and disturbance of wound healing
  •   I49 -  Other cardiac arrhythmias
  •   I20 -  Angina pectoris
  •   I50 -  Heart failure
  •   J18 -  Pneumonia, organism unspecified
  •   I70 -  Atherosclerosis
  •   T88 -  Other complications of surgical and medical care, not elsewhere classified
  •   T81 -  Complications of procedures, not elsewhere classified
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Interventions/Observational Groups

  •   We will perform ultrasonography of the brachial artery. For validation of the exercise capacity, a stair climbing test will be arranged. Patients will be recruited during our preoperative anaesthesiologic visit.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Correlation of brachial artery reactivity with the incidence of postoperative complications.

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Secondary Outcome

Correlation of brachial artery reactivity with preoperative risk factors

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/01/03
  •   170
  •   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

planned surgery with opening of the abdominal thoracic cavity, ASA classification I-III, body weight of 50-120 kg

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Exclusion Criteria

ASA >3, vein thrombosis, lymphedema, dialysis shunt, open wound of upper arm

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Addresses

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    • Klinik für Anästhesiologie und Operative Intensivmedizin, Uniklinik Köln
    • 50937  Köln
    • Germany
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    • Klinik für Anästhesiologie und Operative Intensivmedizin
    • Mr.  Dr. med.  Robert  Schier 
    • Kerpener Straße 62
    • 50937  Köln
    • Germany
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    • Klinik für Anästhesiologie und Operative Intensivmedizin
    • Mr.  Dr. med.  Robert  Schier 
    • Kerpener Straße 62
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Anästhesiologie und Operative Intensivmedizin, Uniklinik Köln
    • Kerpener Straße 62
    • 50937  Köln
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/09/24
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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.