Trial document





This trial has been registered retrospectively.
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  DRKS00015715

Trial Description

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Title

PRe-Operative Prediction of postoperative DElirium by appropriate SCreening

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Trial Acronym

PROPDESC

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Delirium means acute occurring confusion with fluctuating course, consisting of disturbance of attention, awareness and cognition. Postoperative Delirium (POD) is the most common postoperative complication of elderly patients resulting in increased morbidity and mortality. POD appears as hyperactive form with agitation and restlessness, as hypoactive form with lethargy and apathy as well as mixed forms of both. Self-harming behavior as well as lack of involvement in recovery process lead to longer hospital stay with complicated course of treatment. Increased treatment effort with compromised treatment success and sometimes even lasting cognitive impairments and care dependency are the results.
The occurrence of POD correlates with predisposing factors due to age and state of health as well as precipitating factors due to the kind of operation and associated treatment. Aim of our observational study is the development of an instrument to predict the risk of POD from routine preoperative data.

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Brief Summary in Scientific Language

After prospective collection of parameters of medical history, lab values, cognitive assessment and a survey of relatives their correlation with POD is investigated by multivariate analysis. The occurrence of the primary endpoint POD is tested by specific delir assessment from the first to the fifth day after surgery, or after awakening from sedation in intensive care.
The opportunity of prediction of the risk for POD using routine preoperative data is ought to be basis for a subsequent interventional study to reduce the incidence of POD by prevention at patients with high risk for POD. Early detection and treatment of POD can also be an approach to reduce the harm of delirium. In order to develop an instrument for prediction of the risk for POD 1000 patients older than 60 years, planned for elective surgery with expected duration of at least 60 minutes will be included after written consent in the observational study. Secondary endpoints as alteration of quality of life and long-term postoperative cognitive dysfunctions will be assessed 180 days after operation by a phone call.

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Organizational Data

  •   DRKS00015715
  •   2018/12/13
  •   [---]*
  •   yes
  •   Approved
  •   255/17, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
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Secondary IDs

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Health Condition or Problem studied

  •   F05.8 -  Other delirium
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Interventions/Observational Groups

  •   PROPDESC is a prospective observational study and therefore all included patients are observed identically according to the study protocol. There is no intervention.
    The evaluation distinguishes between patients with postoperative delirium and patients without postoperative delirium.
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Characteristics

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

Primary endpoint is the diagnosis of postoperative delirium.
This is diagnosed postoperatively by the
Delirium Observation Scale (DOS) and the Confusion Assesment Method (CAM) as well as the Alertness, Attention, Abbreviated Mental Test (4AT) and the Attention Screening Examination (ASE-Test) on the normal ward.
For the Intensive Care unit the Confusion Assesment Method for Intensive Care Units (CAM-ICU) and the Delirium Observation Scale (DOS) will be used.
Testing takes place from the first to the fifth day after an operation respectively after cessation of sedation.

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Secondary Outcome

Telefon-Follow-up measuring Persistent postoperative cognitive dysfunction and quality of life at 180 days after surgery using Informant Questionnaire on Cognitive Decline in the Elderly (IQ-Code) and the Euro Qol Group 5 Dimensions - 5 Level (EQ-5D-5L) Test.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/09/03
  •   1000
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

- Age over 60 years
- At least 60 minutes of surgery
- Signed declaration of consent of the patients

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Exclusion Criteria

- Patients who undergo emergency surgery
- Patients with language barriers
- Any disease that, in the opinion of the investigator could compromise patient safety or compliance with the study protocol.

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Addresses

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    • Klinik für AnästhesieUniversitätsklinikum Bonn
    • Mr.  Dr. med.  Jan  Menzenbach 
    • Sigmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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    • Klinik und Poliklinik für Anästhesie und operative Intensivmedizin, Universitätsklinikum Bonn
    • Mr.  Dr.  Jan  Menzenbach 
    • Sigmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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    • Klinik und Poliklinik für Anästhesie und operative Intensivmedizin, Universitätsklinikum Bonn
    • Mr.  Dr.  Jan  Menzenbach 
    • Sigmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Bonn
    • Sigmund-Freud-Str. 25
    • 53127  Bonn
    • 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.