DeliriumNCT04320082
Alteration of Blood-Brain-Barrier Permeability at Loss of Consciousness in Delirious Patients Recorded With Direct-Current Electroencephalography (ACDC)
An observational study of Delirium, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
With this trial we aim to characterize the intraoperative signatures of the Direct-Current-Electroencephalogram (DC-EEG) of elderly patients developing a PostOperative Delirium (POD) compared to patients who do not develop a POD. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Delirium
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 10 Aug 2020to 11 Nov 2021
- 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 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elderly Cohort: Patients >70 undergoing elective orthopaedic or trauma surgery under general anaesthesia. Young cohort: Patients between 18 and 30 undergoing elective orthopaedic or trauma surgery under general anaesthesia.
Who may be able to join
- Patients aged >70 years OR between 18 and 30
- Planned operation time >1 hour
- Expected hospital treatment period of 5 days,
- Anesthesia induction, anesthesia maintenance with either Propofol or an inhalative anesthetic agent as Sevoflurane or Desflurane,
- The ability to give informed consent
Who cannot join
- Age under 18 or between 31 and 69
- Patients with a history of neurological or psychiatric disorders
- Planned neurosurgery
- Current medication of tranquilizers / antidepressants
- Isolation of patients with multi-resistant Bacteria
- Inability of the patients to speak and/or read German
- Intraoperative use of ketamine, N²O, Etomidate or Dexmedetomidine
- Participation in a prospective interventional trial
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin
Berlin, 13353
About this study
With this trial we aim to characterize the intraoperative signatures of the Direct-Current-Electroencephalogram (DC-EEG) of elderly patients developing a PostOperative Delirium (POD) compared to patients who do not develop a POD. We hereby intend to gain a better understanding of the electrical potential at the blood-brain-barrier (measured with DC-EEG) during general anaesthesia. Second, we want to study the effect of age on the DC-EEG by comparing a younger (18-30y) to an elderly cohort (>70). Third, we aim to couple the DC-EEG signatures to blood sample analysis in order to understand the relationship between metabolic, inflammatory and vascular reaction with the intraoperative DC-EEG.
Read the detailed description
In order to study the intraoperative DC-EEG signatures of elderly patients coupled with lab data to evaluate the role of the age-dependent blood-brain barrier (BBB) dysfunction in general anesthesia and its meaning in POD pathophysiology following protocol will be followed:
- On the day of the surgery the 21 DC-EEG sintered Ag/AgCl (silver chloride) electrodes will be placed before the start of anesthesia following the 10-20-system.
- The first blood sample will be collected via the routinely placed intravenous catheter.
- During the induction of anesthesia special care will be given to the exact time of loss of consciousness (LOC), defined with the suppression of the lid closure reflex.
- Markers will be set at important time points of the anesthetic care (Baseline, start of analgesia/anesthesia, LOC, intubation, beginning of surgical procedure, end of anesthesia, regain of consciousness, extubation, admission recovery room).
- Shortly after consciousness has vanished (5-10 minutes), a second blood sample will be drawn.
- The DC-EEG recording will last until one hour after arrival at the recovery room, during which NuDesc score will be assessed every 15 minutes.
- A third blood sample is to be collected in the recovery room. In the five days following surgery patients will be visited in the morning and in the evening to screen delirious symptoms with the help of standardized scores (NuDesc, DSM V, DDS). If patients are staying on the intensive care unit the CAM-ICU will be used.
Blood sample analysis will include blood cells count, electrolytes, inflammatory markers, cholesterols, proteins, structural BBB markers and markers of neuronal damage.
- Conditions
- Delirium
- Medical subject headings
- 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 |
|---|---|---|
| Elderly cohort | Patients >70 undergoing elective orthopaedic or trauma surgery under general anaesthesia. | |
| Young cohort | Patients between 18 and 30 undergoing elective orthopaedic or trauma surgery under general anaesthesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. DC-Shift (µV/sec) in the perioperative DC-EEG.
Full-brain DC-EEG with 21 electrodes placed preoperatively following the 10/20-System and recording until one hour after regain of consciousness.
Measured: From the beginning of general anaesthesia to one hour after regain of consciousness
Secondary outcomes (9)
Incidence of Postoperative Delirium
Postoperative Delirium is defined according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V) and/or as ≥ 2 cumulative points in the nursing Delirium Screening Scale (Nu-DESC) and/or a positive Confusion Assessment Method (CAM) and/or Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) score and/or patient chart review that shows descriptions of Delirium.
Measured: Patients will be follow until hospital discharge, or maximal until postoperative day 5
Additional perioperative DC-EEG signatures: morphology, polarity (positive/negative), amplitude (µV)
Full-brain DC-EEG with 21 electrodes placed preoperatively following the 10/20-System and recording until one hour after regain of Consciousness.
Measured: From the beginning of general anaesthesia to one hour after regain of consciousness
DC-EEG signatures in young (18-30) vs. elderly (>70) patients
Full-brain DC-EEG with 21 electrodes placed preoperatively following the 10/20-System and recording until one hour after regain of consciousness
Measured: From the beginning of general anaesthesia to one hour after regain of consciousness
Analysis of pre-, intra- and postoperative blood parameters
Blood samples will be drawn before the start of general anesthesia, shortly after loss of consciousness and in the recovery room.
Measured: : From shortly before the beginning of general anaesthesia to maximum one hour after arrival in the recovery room
Peri-operative, full-brain overall EEG band power
Full-brain EEG recording with surface Ag/AgCl electrodes Spectral analysis by Matlab Code/Lab Chart
Measured: Up to the end of stay in the recovery room
Burst suppression duration
Full-brain EEG recording with surface electrodes, raw EEG analysis
Measured: During anesthesia procedure
Duration of Delirium
Diagnostic and Statistical Manual of Mental Disorders (DSM-V); Nursing Delirium Screening Scale (Nu-DESC), Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), Confusion Assessment Method (CAM), Chart Review
Measured: Participants will be followed for the duration of hospital stay, or maximal until postoperative day 5
Intensive care unit length of stay
The stay is measured in days.
Measured: Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days
Hospital length of stay
The stay is measured in days.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start10 Aug 2020
- Primary completion11 Nov 2021
- Study completion11 Nov 2021
Why it stopped: The study staff has left the clinic.
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.
- 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
- 24 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, Prof., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320082
- Sponsor's protocol ID
- ACDC
- Status last verified
- May 2025
- First submitted
- 23 Mar 2020
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alteration of Blood-Brain-Barrier Permeability at Loss of Consciousness in Delirious Patients Recorded With Direct-Current Electroencephalography (ACDC)
- ClinicalTrials.gov ID
- NCT04320082
- Acronym / sponsor ID
- ACDC
- Conditions
- Delirium
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study staff has left the clinic.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 11 Nov 2021 (actual)
- Study completion
- 11 Nov 2021 (actual)
- First posted
- 24 Mar 2020 (actual)
- 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.
With this trial we aim to characterize the intraoperative signatures of the Direct-Current-Electroencephalogram (DC-EEG) of elderly patients developing a PostOperative Delirium (POD) compared to patients who do not develop a POD. We hereby intend to gain a better understanding of the electrical potential at the blood-brain-barrier (measured with DC-EEG) during general anaesthesia. Second, we want to study the effect of age on the DC-EEG by comparing a younger (18-30y) to an elderly cohort (>70). Third, we aim to couple the DC-EEG signatures to blood sample analysis in order to understand the relationship between metabolic, inflammatory and vascular reaction with the intraoperative DC-EEG.
Detailed description
In order to study the intraoperative DC-EEG signatures of elderly patients coupled with lab data to evaluate the role of the age-dependent blood-brain barrier (BBB) dysfunction in general anesthesia and its meaning in POD pathophysiology following protocol will be followed:
- On the day of the surgery the 21 DC-EEG sintered Ag/AgCl (silver chloride) electrodes will be placed before the start of anesthesia following the 10-20-system.
- The first blood sample will be collected via the routinely placed intravenous catheter.
- During the induction of anesthesia special care will be given to the exact time of loss of consciousness (LOC), defined with the suppression of the lid closure reflex.
- Markers will be set at important time points of the anesthetic care (Baseline, start of analgesia/anesthesia, LOC, intubation, beginning of surgical procedure, end of anesthesia, regain of consciousness, extubation, admission recovery room).
- Shortly after consciousness has vanished (5-10 minutes), a second blood sample will be drawn.
- The DC-EEG recording will last until one hour after arrival at the recovery room, during which NuDesc score will be assessed every 15 minutes.
- A third blood sample is to be collected in the recovery room. In the five days following surgery patients will be visited in the morning and in the evening to screen delirious symptoms with the help of standardized scores (NuDesc, DSM V, DDS). If patients are staying on the intensive care unit the CAM-ICU will be used.
Blood sample analysis will include blood cells count, electrolytes, inflammatory markers, cholesterols, proteins, structural BBB markers and markers of neuronal damage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elderly cohort | – | –Patients >70 undergoing elective orthopaedic or trauma surgery under general anaesthesia. |
| Young cohort | – | –Patients between 18 and 30 undergoing elective orthopaedic or trauma surgery under general anaesthesia. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly Cohort: Patients >70 undergoing elective orthopaedic or trauma surgery under general anaesthesia. Young cohort: Patients between 18 and 30 undergoing elective orthopaedic or trauma surgery under general anaesthesia.
Key inclusion criteria (5 listed)
- Patients aged >70 years OR between 18 and 30
- Planned operation time >1 hour
- Expected hospital treatment period of 5 days,
- Anesthesia induction, anesthesia maintenance with either Propofol or an inhalative anesthetic agent as Sevoflurane or Desflurane,
- The ability to give informed consent
Key exclusion criteria (8 listed)
- Age under 18 or between 31 and 69
- Patients with a history of neurological or psychiatric disorders
- Planned neurosurgery
- Current medication of tranquilizers / antidepressants
- Isolation of patients with multi-resistant Bacteria
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
1. DC-Shift (µV/sec) in the perioperative DC-EEG.
Time frame: From the beginning of general anaesthesia to one hour after regain of consciousness
Full-brain DC-EEG with 21 electrodes placed preoperatively following the 10/20-System and recording until one hour after regain of consciousness.
9 secondary outcomes
Incidence of Postoperative Delirium
Time frame: Patients will be follow until hospital discharge, or maximal until postoperative day 5
Additional perioperative DC-EEG signatures: morphology, polarity (positive/negative), amplitude (µV)
Time frame: From the beginning of general anaesthesia to one hour after regain of consciousness
DC-EEG signatures in young (18-30) vs. elderly (>70) patients
Time frame: From the beginning of general anaesthesia to one hour after regain of consciousness
Analysis of pre-, intra- and postoperative blood parameters
Time frame: : From shortly before the beginning of general anaesthesia to maximum one hour after arrival in the recovery room
Peri-operative, full-brain overall EEG band power
Time frame: Up to the end of stay in the recovery room
Burst suppression duration
Time frame: During anesthesia procedure
Duration of Delirium
Time frame: Participants will be followed for the duration of hospital stay, or maximal until postoperative day 5
Intensive care unit length of stay
Time frame: Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days
Hospital length of stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Results and safety
The study was stopped early (reason given: The study staff has left the clinic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
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RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
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Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
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DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
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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, Prof. study director
Charite University, Berlin, Germany
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 Charite University, Berlin, Germany 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 5 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: stopped early, as of the sponsor's last update on 7 May 2025. 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 was stopped early (reason given: The study staff has left the clinic.). Results are not available in the source record.
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?
1. DC-Shift (µV/sec) in the perioperative DC-EEG. (time frame: From the beginning of general anaesthesia to one hour after regain of consciousness). 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 7 May 2025.