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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Claudia Spies, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01964274
First received: October 15, 2013
Last updated: August 9, 2016
Last verified: August 2016
  Purpose

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.


Condition
Postoperative Delirium

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Relevance of the Peripheral Cholinesterase-activity on Neurocognitive Dysfunctions in Surgical Patients

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Postoperative Delirium [ Time Frame: Participants will be followed in the sample period, an exspected average of three days ] [ Designated as safety issue: No ]
    Postoperative Delirium (measured by Nursing Delirium Screening Scale)


Secondary Outcome Measures:
  • Organ Dysfunctions [ Time Frame: Participants will be followed in the sample period, an exspected average of three days ] [ Designated as safety issue: No ]
  • Concomitant medication [ Time Frame: Participants will be followed in the three postoperative days sample period ] [ Designated as safety issue: No ]
    Concomitant medications from Anticholinergic Drug Scale (ADS)

  • Postoperative Pain [ Time Frame: Participants will be followed in the three postoperative days sample period ] [ Designated as safety issue: No ]
    According to Numeric Rating Scale

  • Duration of Intensive Care Unit Stay [ Time Frame: Participants will be followed in the sample period, an exspected average of seven days ] [ Designated as safety issue: No ]
  • Duration of Hospital Stay [ Time Frame: Participants will be followed in the sample period, an exspected average of four weeks ] [ Designated as safety issue: No ]
  • Duration of Mechanical Ventilation [ Time Frame: Participants will be followed in the sample period, an exspected average of 168 hours ] [ Designated as safety issue: No ]
  • Readmission rate [ Time Frame: Participants will be followed in the sample period, an exspected average of four weeks ] [ Designated as safety issue: No ]
  • Hospital Treatment Data [ Time Frame: Participations will be followed for the duration of the operation day, an exspected time average of eight hours ] [ Designated as safety issue: No ]
    Operation time, surgery, anaesthesia

  • Postoperative Mortality [ Time Frame: Participants will be followed for the duration of the sample period an exspected average of five years ] [ Designated as safety issue: No ]
    Mortality (measured inhouse-mortality according to the patients´records and based on the data record according to §21 Krankenhausentgeltgesetz - (KHEntgG))

  • Postoperative Delirium [ Time Frame: Participants will be followed in the sample period, an exspected average of five years ] [ Designated as safety issue: No ]
    Postoperative Delirium (measured by Diagnosis of Delirium according to the patients´records and based on the data record according to §21 Krankenhausentgeltgesetz -(KHEntgG))

  • Comorbidities [ Time Frame: Participants will be followed in the sample period, an exspected average of five years ] [ Designated as safety issue: No ]
    Comorbidities based on the data record according to §21 Krankenhausentgeltgesetz - (KHEntgG)


Enrollment: 815
Study Start Date: October 2013
Estimated Study Completion Date: December 2019
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Surgical patients
Adult male and female patients undergoing surgery

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult, elective surgery patients of both gender
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01964274

Locations
Germany
Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin
Berlin, Germany, 13353
Department of Anesthesia, Klinik für MIC
Berlin, Germany, 14129
Clinic for Anaesthesiology, Intensive Care Medicine, Palliative Medicine and Pain Medicine, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil
Bochum, Germany, 44789
Department of Anesthesiology, Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Department of Anesthesiology, Klinikum Großhadern of the Ludwig Maximilians University of Munich
München, Germany, 81377
Department of Anesthesiology, Universitätsklinikum Regensburg
Regensburg, Germany, 93053
Department of Anesthesiology, Universitätsklinikum Ulm
Ulm, Germany, 89081
Department of anesthesiology and intensive care medicine
Wetzlar, Germany, 35578
Department of Anaesthesia and Critical Care, Universitätsklinikum Würzburg
Würzburg, Germany, 97080
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Study Director: Claudia Spies, MD Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin
  More Information

Responsible Party: Claudia Spies, Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite - Universitätsmedizin Berlin, Germany, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01964274     History of Changes
Other Study ID Numbers: CESARO 
Study First Received: October 15, 2013
Last Updated: August 9, 2016
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
Nursing Delirium Screening Scale,
Acetylcholinesterase Activity

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

ClinicalTrials.gov processed this record on August 28, 2016