Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00012878

Trial Description

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Title

Perioperative trend of body core temperature in patients undergoing elective trauma and orthopedic surgery

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Before, during or after surgery patients are exposed to a variety of factors limiting their ability to maintain their body core temperature. As a consequence many patients experience an inadvertent perioperative drop in body core temperature, a hypothermia.
Many trials found hypothermia to be associated with increased risk of complications.
In addition to cardial events, surgical site infections are often associated with hypothermia and directly linked to worse outcome. Due to the fact that the current literature is mainly based on patients from a general surgical or gynecological population the incidence of hypothermia and related complications like surgical site infections is unclear and therefor the topic of this study.

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Brief Summary in Scientific Language

observational study to gain knowledge in terms of the incidence and the relevance to the outcome of perioperative hypothermia in patients undergoing elective trauma or orthopedic surgery

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Organizational Data

  •   DRKS00012878
  •   2018/02/28
  •   [---]*
  •   yes
  •   Approved
  •   17-6095-BR, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
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Secondary IDs

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Health Condition or Problem studied

  •   T84.6 -  Infection and inflammatory reaction due to internal fixation device [any site]
  •   T81.4 -  Infection following a procedure, not elsewhere classified
  •   T88.5 -  Other complications of anaesthesia
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Interventions/Observational Groups

  •   The body core temperature of Patients undergoing elective orthopedic or trauma surgery is measured in the preoperative setting. Patients are examined for postoperative complications.
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Characteristics

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

perioperative hypothermia (POH);
Incidences of surgical site infections;
Incidence of postoperative cardial or respiratory infections;
intraoperative blood loss and transfusion need;
postperative mortality

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Secondary Outcome

patient factors contributing to the development of POH; surgical site and duration of surgery

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/11/27
  •   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

elective orthopedic or trauma surgery

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Exclusion Criteria

colonisation or infection with multiresistent germs; open fractures; patient not fully legal competent

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Addresses

  • start of 1:1-Block address primary-sponsor
    • BG Universitätsklinikum Bergmannsheil Bochum
    • Mr.  Dr. med.  Axel  Rand 
    • Bürkle-de-la-Camp-Platz 1
    • 447891  Bochum
    • Germany
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    • BG Universitätsklinikum Bergmannsheil Bochum
    • Mr.  Dr. med.  Axel  Rand 
    • Bürkle-de-la-Camp-Platz 1
    • 447891  Bochum
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • BG Universitätsklinikum Bergmannsheil Bochum
    • Mr.  Dr. med.  Axel  Rand 
    • Bürkle-de-la-Camp-Platz 1
    • 447891  Bochum
    • Germany
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Sources of Monetary or Material Support

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    • Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH
    • Bürkle-de-la-Camp-Platz 1
    • 44789  Bochum
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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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.