DeliriumNCT02315846
Acetylcholinesterase in Postoperative Delirium
An observational study of Delirium, run by Heidelberg University at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2014to Jul 2014
- 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: 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
Who may be able to join
- Signed written informed consent
- Elective surgery
Who cannot join
- Preexisting psychiatric or neurological disease
- No surgery
- Reduced level of consciousness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Acetylcholinesterase for the Diagnosis of Postoperative Delirium in Patients Needing Postoperative Monitoring
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.
- Conditions
- Delirium
- Medical subject headings
- Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
change of acetylcholinesterase (U/l)
change of acetylcholinesterase in units per litre
Measured: one day before surgery, 1-24h after surgery, 25-72h after surgery
Secondary outcomes (4)
change of NuDESC
change of nursing delirium screening score
Measured: one day before surgery, 1-24h after surgery, 25-72h after surgery
change of medication
change of medication, that could influence a delirium
Measured: one day before surgery, 1-24h after surgery, 25-72h after surgery
ICD-codes of main disease
International classification of diseases-code of main disease
Measured: 25-72h after surgery
ICD-codes of coexisting diseases
International classification of diseases-codes of coexisting diseases
Measured: 25-72h after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2014 (estimated)
- Study startJan 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph Schramm, M.D., Heidelberg University
- Investigators
- Konstanze Plaschke, PhD, Study director, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02315846
- Sponsor's protocol ID
- S452/2013
- Status last verified
- May 2018
- First submitted
- 3 Dec 2014
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Acetylcholinesterase for the Diagnosis of Postoperative Delirium in Patients Needing Postoperative Monitoring
- ClinicalTrials.gov ID
- NCT02315846
- Acronym / sponsor ID
- S452/2013
- Conditions
- Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 12 Dec 2014 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (2 listed)
- Signed written informed consent
- Elective surgery
Key exclusion criteria (3 listed)
- Preexisting psychiatric or neurological disease
- No surgery
- Reduced level of consciousness
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
change of acetylcholinesterase (U/l)
Time frame: one day before surgery, 1-24h after surgery, 25-72h after surgery
change of acetylcholinesterase in units per litre
4 secondary outcomes
change of NuDESC
Time frame: one day before surgery, 1-24h after surgery, 25-72h after surgery
change of medication
Time frame: one day before surgery, 1-24h after surgery, 25-72h after surgery
ICD-codes of main disease
Time frame: 25-72h after surgery
ICD-codes of coexisting diseases
Time frame: 25-72h after surgery
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 17 May 2018.
Related trials for Delirium
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
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.
Konstanze Plaschke, PhD study director
Heidelberg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, run by Heidelberg University at 1 site 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 2 inclusion and 3 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 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
change of acetylcholinesterase (U/l) (time frame: one day before surgery, 1-24h after surgery, 25-72h after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2018.