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Clinical Trials/NCT01964274
NCT01964274
Completed
Not Applicable

Relevance of the Peripheral Cholinesterase-activity on Neurocognitive Dysfunctions in Surgical Patients

Charite University, Berlin, Germany9 sites in 1 country815 target enrollmentOctober 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Delirium
Sponsor
Charite University, Berlin, Germany
Enrollment
815
Locations
9
Primary Endpoint
Postoperative Delirium
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

In this prospective, multicenter observational study the investigators capture the perioperative course of peripheral cholinesterase activity. The focus is the perioperative inflammation causing postoperative delirium. Therefore we measure the activity of Acetylcholine-Esterase and Butyrylcholine-Esterase in whole blood of adults in the perioperative context. Early postoperative delirium will be detected by Nu-DESC in the Recovery Room or the Postanaesthesia-Care-Unit. The course of the peripheral cholinesterase activity will be compared with the incidence of postoperative delirium and other clinical dysfunctions.

We follow up the patients for up to five years regarding Delirum, comorbidities and mortality data.

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
July 2016
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Claudia Spies

Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite - Universitätsmedizin Berlin, Germany

Charite University, Berlin, Germany

Eligibility Criteria

Inclusion Criteria

  • Male and female patients with age 18 years and above scheduled for surgery with planned stay in Recovery Room or Postanesthesia-Care-Unit
  • Offered patient information and written informed consent
  • In-hospital stay for at least 24 hours

Exclusion Criteria

  • Patients with known pseudocholinesterase deficiency
  • Participation in prospective intervention studies during the study period
  • Analphabetism
  • Unability of German and English language use
  • Anacusis or Hypoacusis with hearing aid device, Amaurosis
  • Lacking willingness to save and hand out data within the study
  • Accommodation in an institution due to an official or judicial order
  • Coworker of the clinic (study center)

Outcomes

Primary Outcomes

Postoperative Delirium

Time Frame: Participants will be followed in the sample period, an exspected average of three days

Postoperative Delirium (measured by Nursing Delirium Screening Scale)

Secondary Outcomes

  • Organ Dysfunctions(Participants will be followed in the sample period, an exspected average of three days)
  • Concomitant medication(Participants will be followed in the three postoperative days sample period)
  • Postoperative Pain(Participants will be followed in the three postoperative days sample period)
  • Duration of Intensive Care Unit Stay(Participants will be followed in the sample period, an exspected average of seven days)
  • Duration of Mechanical Ventilation(Participants will be followed in the sample period, an exspected average of 168 hours)
  • Readmission rate(Participants will be followed in the sample period, an exspected average of four weeks)
  • Postoperative Mortality(Participants will be followed for the duration of the sample period an exspected average of five years)
  • Duration of Hospital Stay(Participants will be followed in the sample period, an exspected average of four weeks)
  • Hospital Treatment Data(Participations will be followed for the duration of the operation day, an exspected time average of eight hours)
  • Postoperative Delirium(Participants will be followed in the sample period, an exspected average of five years)
  • Comorbidities(Participants will be followed in the sample period, an exspected average of five years)

Study Sites (9)

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