Overview

This trial is active, not recruiting.

Condition postoperative delirium
Sponsor Charite University, Berlin, Germany
Start date October 2013
End date July 2016
Trial size 815 participants
Trial identifier NCT01964274, CESARO

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Adult male and female patients undergoing surgery

Primary Outcomes

Measure
Postoperative Delirium
time frame: Participants will be followed in the sample period, an exspected average of three days

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Relevance of the Peripheral Cholinesterase-activity on Neurocognitive Dysfunctions in Surgical Patients
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Charite University, Berlin, Germany.