Alteration of Blood-Brain-Barrier Permeability at Loss of... | NCT04320082

Studies
Alteration of Blood-Brain-Barrier Permeability at Loss of Consciousness in Delirious Patients Recorded With Direct-Current Electroencephalography (ACDC)

NCT04320082

Sponsor

Charite University, Berlin, Germany

Status

Terminated

Last Update Posted

May 7, 2025Actual

Enrollment

24Actual

Phase

Not provided

Conditions

Delirium

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study staff has left the clinic.

Expanded Access Info

Start Date

Aug 10, 2020Actual

Primary Completion Date

Nov 11, 2021Actual

Completion Date

Nov 11, 2021Actual

First Submitted Date

Mar 23, 2020

First Submission Date that Met QC Criteria

Mar 23, 2020

First Posted Date

Mar 24, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2025

Last Update Posted Date

May 7, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Claudia Spies, Head of the Department of Ansthesiology and Operative Intensive Care Medicine, Charité - Universitätsmedizin Berlin, Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	From the beginning of general anaesthesia to one hour after regain of consciousness

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

110 Years

Standard Ages

AdultOlder 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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Claudia Spies, MD, Prof.	Charite University, Berlin, Germany	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin		Berlin		13353	Germany

Condition Browse Module

MeSH Terms

ID	Term
D003693	Delirium

Ancestor Terms

ID	Term
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided