NCT02315846

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 12, 2014

Completed
Last Updated

May 17, 2018

Status Verified

May 1, 2018

Enrollment Period

6 months

First QC Date

December 3, 2014

Last Update Submit

May 11, 2018

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

  • change of acetylcholinesterase (U/l)

    change of acetylcholinesterase in units per litre

    one day before surgery, 1-24h after surgery, 25-72h after surgery

Secondary Outcomes (4)

  • change of NuDESC

    one day before surgery, 1-24h after surgery, 25-72h after surgery

  • change of medication

    one day before surgery, 1-24h after surgery, 25-72h after surgery

  • ICD-codes of main disease

    25-72h after surgery

  • ICD-codes of coexisting diseases

    25-72h after surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Signed written informed consent
  • Elective surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Heidelberg

Heidelberg, 69120, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood-serum

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Konstanze Plaschke, PhD

    Heidelberg University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 3, 2014

First Posted

December 12, 2014

Study Start

January 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

May 17, 2018

Record last verified: 2018-05

Locations

DE(1)