Acetylcholinesterase in Postoperative Delirium | NCT02315846

Studies
Acetylcholinesterase in Postoperative Delirium

NCT02315846

Sponsor

Heidelberg University

Status

Completed

Last Update Posted

May 17, 2018Actual

Enrollment

120Actual

Phase

Not provided

Conditions

Delirium

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Dec 3, 2014

First Submission Date that Met QC Criteria

Dec 9, 2014

First Posted Date

Dec 12, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2018

Last Update Posted Date

May 17, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

120Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
change of NuDESC	change of nursing delirium screening score	one day before surgery, 1-24h after surgery, 25-72h after surgery
change of medication	change of medication, that could influence a delirium

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed written informed consent
Elective surgery

Exclusion Criteria:

Preexisting psychiatric or neurological disease
No surgery
Reduced level of consciousness

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Konstanze Plaschke, PhD	Heidelberg University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Heidelberg		Heidelberg		69120	Germany

Condition Browse Module

MeSH Terms

ID	Term
D003693	Delirium

Ancestor Terms

ID	Term
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided