Trial document




drksid header

  DRKS00017178

Trial Description

start of 1:1-Block title

Title

Perioperative Assessment of plasmacholinesterase activity via a POCT device for early identification of high-risk patients for postoperative delirium

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

/

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http:///

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

[---]*

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language


Postoperative delirium is a common complication in very old-age patients. The current data suggest that there is a correlation between the occurrence of postoperative delirium and impaired acetylcholine / dopamine metabolism in the central nervous system. The surrogate markers for the central acetylcholine concentration are the serum butyryl / acetylcholinesterase activity (BChE / AChE). Towards lower central acetylcholine concentration the body responds with a consecutive decrease in AChE (which should result in elevation of the central nervous acetylcholine level).
The aim of this study is to use a point-of-care test system (POCT) to measure the pre- and perioperative AChE / BChE of the study participants and to correlate this with the occurrence of postoperative delirium. The underlying hypothesis is that patients with a decreased preoperative or perioperative value are more likely to develop postoperative delirium.
The study population is recruited from volunteer patients who are undergoing elective or emergency surgery.
Inclusion criterion is an age above 70 years, exclusion criteria are an already diagnosed dementia disease as well as a drug-based anti-dementive therapy.
The patient's risk of postoperative delirium is estimated preoperatively using the following screening modalities: age, mini mental status test (MMST), clock drawing test, frailty score (Fried), mini nutritional assessment (MNA), geriatric depression scale (GDS), anticholinergic burden scale (ABS) and comorbidities (Charlson Comorbidity Score). At the same time with preoperative routine blood collection, an additional EDTA blood tube is obtained to determine the preoperative AChE / BChE. In the intensive care unit, delirium is assessed postoperatively using the established CAM-ICU ("Confusion Assessment Method for the Intensive Care Unit", every 8 h). On the normal ward the screening with the CAM ("Confusion Assessment Method") is performed twice a day. In addition to routine blood sampling on the 1./3. postoperative day one additional EDTA tube is obtained for the reassessment of the AChE / BChE. This results in no additional blood collection from the patient.
Subsequently, the present values ​​for AChE / BChE are correlated with the results of delirium screening. Additionaly results of the preoperative assessmentn will also be correlated and analyzed.
We want to investigate the following hypothesis:
Patients that suffer from postoperative delirium also have either a significantly lower preoperative plasmacholinesterase activity or show a higher decrease in plasmacholinesterase activity after the the operation.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00017178
  •   2019/04/24
  •   [---]*
  •   yes
  •   Approved
  •   2018-561-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   F05.8 -  Other delirium
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients undergoing elective surgery.
    Preoperative geriatric assessment for the evaluation of delirium risk (MMST, clock drawing test, MNA, GDS, ABS, Charlson Comorbidity Score, Frailty Score), on the day of surgery preoperative blood collection with i.v. line placement and bedside determination of acetylcholine / butyrylcholinesterase activity via POCT device, on 1./3. postoperative day blood collection in the context of routine blood sampling and bedside determination of acetylcholine / butyrylcholinesterase activity via POCT device, on the 1st-3rd postoperative day screening for postoperative Delirium using the CAM / CAM-ICU twice a day.
  •   Patients undergoing emergency surgery.
    Preoperative geriatric assessment for the evaluation of delirium risk (MMST, clock drawing test, MNA, GDS, ABS, Charlson Comorbidity Score, Frailty Score), on the day of surgery preoperative blood collection with i.v. line placement and bedside determination of acetylcholine / butyrylcholinesterase activity via POCT device, on 1./3. postoperative day blood collection in the context of routine blood sampling and bedside determination of acetylcholine / butyrylcholinesterase activity via POCT device, on the 1st-3rd postoperative day screening for postoperative delirium using the CAM / CAM-ICU twice a day.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Screening
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Incidence of postoperative delirium in both studygroups, measured twice a day using the Confusion Assessment Method/Confusion Assessment Method for the ICU in the timeframe between the 1st and 3rd postoperative day.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Analysis of differences in plasmacholinesterase activity, differences in geriatric assessment

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2019/04/25
  •   150
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   70   Years
  •   120   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Patients of age 70 or above undergoing an elective/emergency operation

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Diagnosed dementia with anti-dementive, pharmacologic therapy

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • St. Franziskus-Hospital GmbHKlinik für Anästhesie und Operative Intensivmedizin
    • Mr.  Prof. Dr. med.  Ulrich  Göbel 
    • Hohenzollernring 70
    • 48145  Münster
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • St. Franziskus-Hospital GmbHKlinik für Anästhesie und Operative Intensivmedizin
    • Ms.  Dr. med.  Simone  Gurlit 
    • Hohenzollernring 70
    • 48145  Münster
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • St. Franziskus-Hospital GmbHKlinik für Anästhesie und operative Intensivmedizin
    • Ms.  Stefanie  Hock 
    • Hohenzollernring 70
    • 48145  Münster
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • St. Franziskus-Hospital GmbHKlinik für Anästhesie und Operative Intensivmedizin
    • Mr.  Prof. Dr. med.  Ulrich  Göbel 
    • Hohenzollernallee 70
    • 48145  Münster
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.