Trial document




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  DRKS00015637

Trial Description

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Title

Perioperatively-Acquired Weakness

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Trial Acronym

POAW

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URL of the Trial

[---]*

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Brief Summary in Lay Language

It is a well-known concomitant that intensive care patients suffer from acquired muscle weakness that can negatively affect the acute course of the disease and long-term recovery. This muscle breakdown is initiated by immobilization and inflammatory reactions. There is clear evidence that this muscle breakdown begins within a few hours and may even occur during surgery. The acquired muscle damage can then have a significant impact on the recovery process of patients, even if they do not require intensive care treatment. An association with postoperative complications such as hospital acquired pneumonia and immobility seems plausible.
The aim of the study is to investigate if and which patients already suffer from muscle weakness after surgery or after anesthesia for an examination. Both the muscle mass and function of the extremities, as well as the respiratory muscles are examined. Furthermore, the aim of the study is to identify risk factors that lead to the development of muscle weakness. In addition, external influencing factors such as duration and kind of surgery, as well as laboratory investigations, which map the inflammatory process in the body as well as the metabolic pathways for the regulation of the skeletal muscle mass are examined.

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Brief Summary in Scientific Language

Muscle weakness acquired in the intensive care unit is associated with poor outcome in terms of muscle strength and function as well as reduced health-related quality of life. Muscle loss is favored by immobilization and inflammation and is ubiquitous in the intensive care unit. There is clear evidence that this muscle breakdown can occur within a few hours or even perioperatively. Perioperative muscle loss can then have a significant impact on the recovery process of patients, even if they do not require intensive care treatment. An association with postoperative complications such as pneumonia and immobility seems plausible.
The aim of the study is to investigate whether and which patients already develop muscle weakness through the perioperative course. Both the muscle mass and function of the extremities, as well as the respiratory muscles are examined.
Furthermore, the aim of the study is to identify risk factors that lead to the development of significant muscle weakness. To describe the risk factors we also includes the determination of the inflammatory immune response of the patient from the blood. Interleukins and cortisol have a significant effect on muscle metabolism and were induced intraoperatively. Whether a direct connection exists here has be investigated.

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Organizational Data

  •   DRKS00015637
  •   2018/12/10
  •   [---]*
  •   yes
  •   Approved
  •   EA2/221/17, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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

  •   M62.5 -  Muscle wasting and atrophy, not elsewhere classified
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Interventions/Observational Groups

  •   Patients with elective surgery without tumor disease without significant comorbidities.
  •   Patients undergoing anesthesia without surgery (e.g., MRI or CT diagnosis under general anesthesia) to differentiate the operative stressor from the influence of anesthesia itself
  •   Patients with elective tumor surgery often associated with tumor sarcopenia, which may affect muscle weakness
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Diagnostic
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Loss of muscle strength on the first postoperative day measured by hand grip strength (hand grip strength measured by dynamometry on both sides)

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Secondary Outcome

- Questionnaire on Physical Independence (Functional Independence Measure)
- Clinical muscle strenght measurement (MRC score)
- lung function tests
- Ultrasound examination of the musculature
- 6-minute walking test
- indirect calorimetry

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/11/27
  •   100
  •   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

- Patients undergoing elective surgery at the Charité
- Patients undergoing elective diagnostics in General anaesthesia at the Charité
- written consent of the patient

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Exclusion Criteria

- Age <18 years
- Participation in another study
- neuromuscular disease
- lack of consent of the patient
- pregnancy

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Addresses

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    • Charité Campus Virchow-Klinikum
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Charité - Universitätsmedizin BerlinKlinik für Anästhesiologie m.S. operative Intensivmedizin
    • Mr.  Dr. med.  Tobias  Wollersheim 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Charité - Universitätsmedizin BerlinKlinik für Anästhesiologie m.S. operative Intensivmedizin
    • Mr.  Dr. med.  Tobias  Wollersheim 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Charité - Universitätsmedizin BerlinKlinik für Anästhesiologie m.S. operative Intensivmedizin
    • Mr.  Dr. med.  Tobias  Wollersheim 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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