Trial document




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  DRKS00004776

Trial Description

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Title

Perioperative complications in obese and non-obese patients: Prevention and treatment of wound infections and post-operative pain.
Prospective, open, monocentric study to investigate perioperative tissue concentrations of antibiotics and regional analgesics using microdialysis in obese and non-obese patients.

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Trial Acronym

Mikrodialyse

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URL of the Trial

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Brief Summary in Lay Language

Standard drug-dose-models for perioperative antibiotic prophylaxis has been developed for non-obese patients. These date are not available for obese patients for antibiotic prophylaxis aswell as pain therapy. For improvement of the therapy it is essential to know the drug action. Using the microdialysis technique it is now possible to analyse the drug concentration in the tissue and to get data about their action.

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Brief Summary in Scientific Language

The goal of this study is to investigate if using the standard drug-dose-model within obese and non-obese patients enough drug concentration is determined in the subcutaneous tissue. Therefore we will determine the concentration of antibiotics and analgesics in the tissue fluid of the subcutaneous tissue as well as in the soft tissue of the operated regions to develop an adequate drug-dose-model.

Due to the protocol amendment 01, the Micodialyse study was expanded to include a further product group. Thus, the patient number increased from 90 to 120. The amendment 01 was approved by the ethics committee of the University of Leipzig on December 11 2014

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Organizational Data

  •   DRKS00004776
  •   2013/08/27
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  •   yes
  •   Approved
  •   121-13-ff, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

  •   2012-004383-22 
  •   4038808 
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Health Condition or Problem studied

  •   10054711 (Postoperative pain)
  •   R52 -  Pain, not elsewhere classified
  •   10036410 (Postoperative wound infection)
  •   T81.4 -  Infection following a procedure, not elsewhere classified
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Interventions/Observational Groups

  •   Group1:
    will receive 600 mg Linezolid plus
    1000 mg Meropenem and 1000 mg Paracetamol or 1000 mg Metamizol
    Group 2:
    will receive 100 mg Tigecyclin and 1000 mg Paracetamol or 1000 mg Metamizol
    Group 3:
    will receive 2000 mg Cefazolin plus 500 mg Metronidazol and 1000 mg Paracetamol or 1000 mg Metamizol
    Group 4:
    will receive 8 g Fosfomycin plus 4,5 g Piperacellin/Tazobactam and 1000 mg Paracetamol or 1000 mg Metamizol
  •   The control group consists of non-obese patients (matching age, gender and kind of surgery) who will be treated the same way than the matching obese patients.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Other
  •   Parallel
  •   III
  •   No
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Primary Outcome

The area under the concentration-time-curve (AUC0-8) of the investigated antibiotics in the interstitial fluid from patients of one of the drug groups (1 to 3). Samples will be taken up to 8 hours after start of study medication. If a drug group consists of more than one antibiotic the data analyses of concentrations will be performed separately.

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Secondary Outcome

All concentrations mentioned below will be investigated in the interstitial fluid as well as in plasma (if not otherwise specified).
- Area under the concentration-time-curve (AUC) for plasma
- Maximal concentration (Cmax)
- Cmax/MIC (MIC = minimal inhibitory concentration)
- Time to exceed MIC
- Concentration at the time of surgical suture
- AUCtissue/AUCplasma Relation
- PK/PD-Parameter (Pharmacokinetics/Pharmacodynamics)
- Half-life (t1/2)
- Concentration of the substances of interest in the tissue taken during surgery
- Incidence of wound infections
- postoperative pain scoring
Samples will be taken up to 8 hours after start of study medication.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/10/28
  •   120
  •   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

- BMI ≥ 18.5 kg/m² and BMI < 30 kg/m²
- age ≥ 18 years
- patients undergoing an abdominal surgery and needing a perioperative prophylactic antibiotic and analgesics
- Written informed consent of the patient

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Exclusion Criteria

- Patients who have received the study medication within the 72 hours before surgery
- known allergic reactions or contra-indications to any of the study medications
- pregnant or breast-feeding women (positive pregnancy test for pre-menopausal women)
- participation in another interventional AMG study (studies falling in the jurisdiction of German Drug Law)

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Addresses

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    • Klinik und Poliklinik für Anästhesiologie und Intensivtherapie Universitätsklinikum Leipzig AöR
    • Mr.  Prof. Dr.  Hermann  Wrigge 
    • Liebigstr. 20
    • 04103  Leipzig
    • Germany
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    • Universität Leipzig Medizinische Fakultät ZKS Leipzig - KKS
    • Ms.  Dr.  Christiane  Prettin 
    • Härtelstr. 16-18
    • 04107  Leipzig
    • Germany
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    • Klinik und Poliklinik für Anästhesiologie und Intensivtherapie Universitätsklinikum Leipzig AöR
    • Mr.  Dr.  Philipp  Simon 
    • Liebigstr. 20
    • 04103  Leipzig
    • Germany
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    • Klinik und Poliklinik für Anästhesiologie und Intensivtherapie Universitätsklinikum Leipzig AöR
    • Mr.  Dr.  Philipp  Simon 
    • Liebigstr. 20
    • 04103  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/03/21
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Trial Publications, Results and other Documents

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