Trial document




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  DRKS00012797

Trial Description

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Title

Markers and predictors of delirium after elective surgery in the elderly

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Trial Acronym

PAWEL-R

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URL of the Trial

http://nicht vorhanden

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

The incidence of a Postoperative delirium (POD) is dependent on several risk factors as age, brain damage, dementia, deficits in cognitive, sensory or mobility functions, multimorbidity, polypharmacy (Guenther, Riedel et al., 2016) and frailty (Leung et al., 2011). The incidence of delirium, its severity and duration can be significantly decreased taking care of the delirium risk factors (RR 0.69, 95% CI 0.59 - 0.81) (Siddiqi, Harrison et al., 2016). Early indicators of cognitive deficits (hyposmia (Brown, Morrissey et al., 2015), sleep disorders (Todd, Gellrich et al., Patel, Baldwin et al., 2014) and subjective as well as objective memory impairment (Hagen, Ehlis et al., Wolfsgruber et al., 2014)) are also relevant for delirium and will here be integrated for the first time into a delirium risk score for elective procedures.

The study PAWEL-R is (R like Risk estimation) will aim to a delirium risk score. It will be extended in autumn 2017 to the PAWEL study including prevention and mangement of POD. Both studies PAWEL and PAWEL-R are funded by the Innovationsfonds (AZ:VF1_2016-201).

The study PAWEL-R will explore clinical and biological risk factors in 750 patients above 70 years at 5 centers in southwest Germany, who will have elective surgery to heart, vessels, big joints and spinal cord of a duration of more than 1 hour. Beside well established rsk factors like age and cognitive impairment, renal failure) new factors will be analysed (further details are given in Arm 1). In a further step the new risk score will be validated in a second sample of patients up to 1050 patients. The prevalence of postoperative delirium (POD) will be assessed for 7 days by independent raters (I-CAM).
Risk scores are developed in the development cohort using logistic regression models based on the gold standard, with bootstrapping procedures and regression weights adjusted clinical scores being tested incrementally for their predictive validity. In the validation hierarchy, the scores thus found are again cross-validated using logistic regression models based on the gold standard and bootstrapping methods.
At three sites, blood-based biomarkers (such as markers of neurodegeneration, neurotrophins, inflammatory markers, genetic markers and micro-RNAs) are collected in a biobank and evaluated after finding a third-party agent. In Tübingen neurophysiological markers (fNIRS) and EEG (also in Stuttgart) are preoperatively collected on a subgroup of 75 and 100 patients, respectively. To this end, a biomarkerboard with several responsible persons from each site (in addition to the PI Gerhard Eschweiler) is established for the methodology. Without previous funding are the analysis of blood-based biomarkers and electrophysiological markers in the EEG and fNIRS. The acquired biomarkers are investigated exploratively in the risk models.

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Organizational Data

  •   DRKS00012797
  •   2017/07/31
  •   [---]*
  •   yes
  •   Approved
  •   233/2017BO1, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

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Health Condition or Problem studied

  •   F05.0 -  Delirium not superimposed on dementia, so described
  •   F05.1 -  Delirium superimposed on dementia
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Interventions/Observational Groups

  •   Development of
    1) a clinical practicable Delirium risk score for patients above 70 years for elective surgery and validation in an independent subsample including
    established rick factors (age, multimorbidity)
    a) cognitive impairment (MOCA Score, digit span backwards, TMT A und B)
    b) dementia
    c) renal failure
    d) alcohol consumption (>3 drinks/day)
    e) smoking (>5 cigarettes/day)
    f) multimedication
    g) impairment of vision and hearing
    h) anticholinergic drugs

    inovative factors
    a) Sleeping impairment and sleep apnoea
    b) Hand grip
    c) Frailty Score
    d) odor recognition (Sniffin Sticks 12)
    e) Subjective memory impairment (SMI)
    f) Barthel-Index

    perisurgical factors (type of surgery, Duration and type of anesthesia, bllod loss, Pain medication and others)

    protective factors:
    education

    primary endpoint:
    prevalence of POD by CAM Assessment within day one to 7 at 5 centers.


    Additionally at three centers (Tübingen, Stuttgart, Ulm) blood based biomarkers are collected, frozen and stored preoperative and postoperative (day 5-8): responsible G. Eschweiler, PD Dr. C. Thomas, Stuttgart, Prof Dr. von Arnim Ulm and others members of the Biomarkerboard)
    a) Markers of Neurodegeneration
    b) Neurotrophines
    c) Markers of inflammation
    d) Risk genes for Delrium and dementia
    e) mikro-RNA
    The analyses weill be done, when a third party funding is found.

    At two centers (Tübingen and Stuttgart) neurophysiological markers will be sampled by
    a) fNIRS (functional near infraed-spectroscopy) at resting state and during executive tasks in a subsample of 75 subjects, responsible Dr. Florian Metzger, Geriatric Center Tübingen
    b) EEG Preoperative during resting state in a subsample of 50 subjects at each site (responsible Dr. Daniel Weiss, University Hospital of Neurology)
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Characteristics

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

prevalence of Delirium (F05.0) on criteria of CAM within 7 days postsurgery

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Secondary Outcome

Delirium Severirty and subtypes

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2017/07/11
  •   750
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   70   Years
  •   no maximum age
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Additional Inclusion Criteria

elective surgery longer than 1 h, heart, thorax, vessels, big joints and spinal cord,

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Exclusion Criteria

Emergency surgery, severe dementia without ability to give informed consent, insufficient ability to understand German,

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Addresses

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    • Universitätsklinikum TübingenGeriatrisches Zentrum
    • Mr.  Prof. Dr. med.  Gerhard  Eschweiler 
    • Calwerstrasse 14
    • 72070  Tübingen
    • Germany
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    • Geriatrisches Zentrum am Universitätsklinikum Tübingen
    • Mr.  Prof. Dr. med.  Gerhard  Eschweiler 
    • Calwerstrasse 14
    • 72070  Tübingen
    • Germany
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    • Sozial- und Präventivmedizin, Universität Potsdam (verantwortlich für die Methodik)
    • Mr.  Professor Dr. Dr.  Michael  Rapp 
    • Am Neuen Palais 10
    • 14469  Potsdam
    • Germany
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    • Städtisches Klinikum Stuttgart Bad Cannstadt (verantwortklich für Schulung und Delirerkennung) Klinik für Alterspsychiatrie
    • Ms.  PD Dr. med.  Christine  Thomas 
    • Prießnitzweg 24
    • 70374  Stuttgart
    • Germany
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    • Geriatrisches Zentrum am Universitätsklinikum Tübingen
    • Mr.  Prof. Dr. med.  Gerhard  Eschweiler 
    • Calwerstrasse 14
    • 72070  Tübingen
    • Germany
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Sources of Monetary or Material Support

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    • Innovationsausschuss beim Gemeinsamen BundesausschussProjektträger DLR
    • Wegelystr. 8
    • 10623  Berlin
    • Germany
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Status

  •   Enrolling by invitation
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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.