Postoperative DeliriumCESARONCT01964274
Relevance of the Peripheral Cholinesterase-activity on Neurocognitive Dysfunctions in Surgical Patients
An observational study of Postoperative Delirium, run by Charite University, Berlin, Germany at 9 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Delirium
- How many people
- 815 participants
- Where
- 9 sitesGermany
- Study dates
- Oct 2013to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult, elective surgery patients of both gender
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Germany9 sites
Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin
Berlin, 13353
Department of Anesthesia, Klinik für MIC
Berlin, 14129
Clinic for Anaesthesiology, Intensive Care Medicine, Palliative Medicine and Pain Medicine, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil
Bochum, 44789
Department of Anesthesiology, Universitätsklinikum Heidelberg
Heidelberg, 69120
Department of Anesthesiology, Klinikum Großhadern of the Ludwig Maximilians University of Munich
München, 81377
Department of Anesthesiology, Universitätsklinikum Regensburg
Regensburg, 93053
Department of Anesthesiology, Universitätsklinikum Ulm
Ulm, 89081
Department of anesthesiology and intensive care medicine
Wetzlar, 35578
Department of Anaesthesia and Critical Care, Universitätsklinikum Würzburg
Würzburg, 97080
About this study
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.
- Conditions
- Postoperative Delirium
- Keywords
- Nursing Delirium Screening Scale,, Acetylcholinesterase Activity
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Surgical patients | Adult male and female patients undergoing surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Delirium
Postoperative Delirium (measured by Nursing Delirium Screening Scale)
Measured: Participants will be followed in the sample period, an exspected average of three days
Secondary outcomes (11)
Organ Dysfunctions
Measured: Participants will be followed in the sample period, an exspected average of three days
Concomitant medication
Concomitant medications from Anticholinergic Drug Scale (ADS)
Measured: Participants will be followed in the three postoperative days sample period
Postoperative Pain
According to Numeric Rating Scale
Measured: Participants will be followed in the three postoperative days sample period
Duration of Intensive Care Unit Stay
Measured: Participants will be followed in the sample period, an exspected average of seven days
Duration of Hospital Stay
Measured: Participants will be followed in the sample period, an exspected average of four weeks
Duration of Mechanical Ventilation
Measured: Participants will be followed in the sample period, an exspected average of 168 hours
Readmission rate
Measured: Participants will be followed in the sample period, an exspected average of four weeks
Hospital Treatment Data
Operation time, surgery, anaesthesia
Measured: Participations will be followed for the duration of the operation day, an exspected time average of eight hours
Postoperative Mortality
Mortality (measured inhouse-mortality according to the patients´records and based on the data record according to §21 Krankenhausentgeltgesetz - (KHEntgG))
Measured: Participants will be followed for the duration of the sample period an exspected average of five years
Postoperative Delirium
Postoperative Delirium (measured by Diagnosis of Delirium according to the patients´records and based on the data record according to §21 Krankenhausentgeltgesetz -(KHEntgG))
Measured: Participants will be followed in the sample period, an exspected average of five years
Comorbidities
Comorbidities based on the data record according to §21 Krankenhausentgeltgesetz - (KHEntgG)
Measured: Participants will be followed in the sample period, an exspected average of five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 815 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Study director, Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964274
- Sponsor's protocol ID
- CESARO
- Acronym
- CESARO
- Status last verified
- Aug 2019
- First submitted
- 15 Oct 2013
- Last updated
- 21 Aug 2019
- Results posted
- No
Publications
Muller A, Olbert M, Heymann A, Zahn PK, Plaschke K, von Dossow V, Bitzinger D, Barth E, Meister M, Kranke P, Herrmann C, Wernecke KD, Spies CD. Relevance of peripheral cholinesterase activity on postoperative delirium in adult surgical patients (CESARO): A prospective observational cohort study. Eur J Anaesthesiol. 2019 Feb;36(2):114-122. doi: 10.1097/EJA.0000000000000888.
PubMed 30431498Michels B, Holzamer A, Graf BM, Bredthauer A, Petermichl W, Muller A, Zausig YA, Bitzinger DI. Butyrylcholinesterase as a perioperative complication marker in patients after transcatheter aortic valve implantation: a prospective observational study. BMJ Open. 2021 Jul 6;11(7):e042857. doi: 10.1136/bmjopen-2020-042857.
PubMed 34230011
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relevance of the Peripheral Cholinesterase-activity on Neurocognitive Dysfunctions in Surgical Patients
- ClinicalTrials.gov ID
- NCT01964274
- Acronym / sponsor ID
- CESARO / CESARO
- Conditions
- Postoperative Delirium
- Keywords
- Nursing Delirium Screening Scale,, Acetylcholinesterase Activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 815 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 17 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical patients | – | –Adult male and female patients undergoing surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult, elective surgery patients of both gender
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
11 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Results publication: PubMed 30431498Muller A, Olbert M, Heymann A, Zahn PK, Plaschke K, von Dossow V, Bitzinger D, Barth E, Meister M, Kranke P, Herrmann C, Wernecke KD, Spies CD. Relevance of peripheral cholinesterase activity on postoperative delirium in adult surgical patients (CESARO): A prospective observational cohort study. Eur J Anaesthesiol. 2019 Feb;36(2):114-122. doi: 10.1097/EJA.0000000000000888.
- Derived from this study: PubMed 34230011Michels B, Holzamer A, Graf BM, Bredthauer A, Petermichl W, Muller A, Zausig YA, Bitzinger DI. Butyrylcholinesterase as a perioperative complication marker in patients after transcatheter aortic valve implantation: a prospective observational study. BMJ Open. 2021 Jul 6;11(7):e042857. doi: 10.1136/bmjopen-2020-042857.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Spies, MD study director
Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Delirium, run by Charite University, Berlin, Germany at 9 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Delirium (time frame: Participants will be followed in the sample period, an exspected average of three days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01964274, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.