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Acetylcholinesterase in Postoperative Delirium

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ClinicalTrials.gov Identifier: NCT02315846
Recruitment Status : Completed
First Posted : December 12, 2014
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Christoph Schramm, M.D., Heidelberg University

Brief Summary:
The level of acetylcholinesterase is suspected to correlate with postoperative delirium. The investigators therefore score patients once preoperatively and twice postoperatively with the german version of the delirium-score NuDESC (Nursing Delirium Screening Scale) and compare the results with the acetylcholinesterase activity, butyrylcholinesterase activity and the serum anticholinergic activity (SAA) at corresponding time points.

Condition or disease
Delirium

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Role of Acetylcholinesterase for the Diagnosis of Postoperative Delirium in Patients Needing Postoperative Monitoring
Study Start Date : January 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium




Primary Outcome Measures :
  1. change of acetylcholinesterase (U/l) [ Time Frame: one day before surgery, 1-24h after surgery, 25-72h after surgery ]
    change of acetylcholinesterase in units per litre


Secondary Outcome Measures :
  1. change of NuDESC [ Time Frame: one day before surgery, 1-24h after surgery, 25-72h after surgery ]
    change of nursing delirium screening score

  2. change of medication [ Time Frame: one day before surgery, 1-24h after surgery, 25-72h after surgery ]
    change of medication, that could influence a delirium

  3. ICD-codes of main disease [ Time Frame: 25-72h after surgery ]
    International classification of diseases-code of main disease

  4. ICD-codes of coexisting diseases [ Time Frame: 25-72h after surgery ]
    International classification of diseases-codes of coexisting diseases


Biospecimen Retention:   Samples Without DNA
blood-serum


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive adult patients in the head clinic of the University of Heidelberg, Germany with surgery, that requires them to stay in Hospital for at least 3 days postoperatively
Criteria

Inclusion Criteria:

  • Signed written informed consent
  • Elective surgery

Exclusion Criteria:

  • Preexisting psychiatric or neurological disease
  • No surgery
  • Reduced level of consciousness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315846


Locations
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Germany
University of Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Investigators
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Study Director: Konstanze Plaschke, PhD Heidelberg University

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Responsible Party: Christoph Schramm, M.D., Principal Investigator, Heidelberg University
ClinicalTrials.gov Identifier: NCT02315846     History of Changes
Other Study ID Numbers: S452/2013
First Posted: December 12, 2014    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders