DeliriumNCT04920734
Description of Therapy Options and Successes in the Long-term Course of Delirium in the Recovery Room - CESARO II
An observational study of Delirium, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
This project is a multicenter pilot project to evaluate the therapeutic success in the long term up to 3 months after a delirium in a recovery room. There is a Europe-wide recommendation for the prevention of postoperative delirium in older patients and the evidence and consensus-based guideline "Management of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- How many people
- 5 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2021to 30 Mar 2022
- 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 patients admitted to the recovery room who have been diagnosed with delirium
Who may be able to join
- All patients admitted to the recovery room who have been diagnosed with delirium according to the treating physicians
- The patient is on a ward in the hospital
- Age ≥ 18 years
- Stay in the recovery room ≥ 1 day
- The patient is able to give consent
Who cannot join
- Participation in a prospective intervention study (except adjuvant therapy study)
- Patients with underlying neurological diseases that make it difficult to differentiate from delirium
- Missing contact 3 months after stay in the recovery room.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin
Berlin, 13353
About this study
Official title: Description of Therapy Options and Successes in the Long-term Course of Delirium in the Recovery Room - Multicenter Observational Study (CESARO-2)
This project is a multicenter pilot project to evaluate the therapeutic success in the long term up to 3 months after a delirium in a recovery room. There is a Europe-wide recommendation for the prevention of postoperative delirium in older patients and the evidence and consensus-based guideline "Management of delirium, analgesia and sedation in intensiv care medicine" of the AWMF (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften) are regularly updated for the detection and treatment of delirium in the intensive care unit. The aim is to evaluate the effects of a systematic delirium screening and the delirium treatment options in the long term in the same way as the current recommendations for the patient cohort of the recovery room.
- Conditions
- Delirium
- Medical subject headings
- Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity
Postoperative complications according to Clavien-Dindo classification
Measured: Up to three months
Secondary outcomes (22)
Duration of delirium
Duration of delirium is measured in days
Measured: Time until discharge from recovery room, an expected average of 5 days
Incidence of delirium
Postoperative delirium rate, 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: Time until discharge from recovery room, an expected average of 5 days
Preventive measures against delirium 1
Preventive measures of delirium are measured by medical treatments
Measured: Time until discharge from recovery room, an expected average of 5 days
Preventive measures against delirium 2
Preventive measures of delirium are measured by non-medical treatments
Measured: Time until discharge from recovery room, an expected average of 5 days
Anticholinergic drugs
Measured by anticholinergic drug scale
Measured: Time until discharge from hospital, an expected average of 7 days
Treatment of delirium
Treatment of delirium with medication
Measured: Time until discharge from hospital, an expected average of 7 days
Measurement of acetylcholinesterase
Measurement of activities of the enzyme - acetylcholinesterase in blood
Measured: Time until discharge from recovery room, an expected average of 5 days
Measurement of butyrylcholinesterase
Measurement of activities of the enzyme - butyrylcholinesterase in blood
Measured: Time until discharge from recovery room, an expected average of 5 days
Chronic comorbid diseases
Chronic comorbid diseases (comorbidities) are measured by Charlson comorbidity index
Measured: Time until discharge from hospital, an expected average of 7 days
Health related quality of life
EQ-5D
Measured: Up to three months
Treatment of vegetative symptoms
Treatment of vegetative symptoms is measured by vegetative medical therapy
Measured: Time until discharge from recovery room, an expected average of 5 days
Treatment of pain
Treatment of pain is measured by analgesia
Measured: Time until discharge from recovery room, an expected average of 5 days
Treatment of postoperative vomiting
Treatment of postoperative vomiting is measured by anti-emetics
Measured: Time until discharge from recovery room, an expected average of 5 days
Treatment of productive psychotic symptoms
Treatment of productive psychotic symptoms is measured by anti-psychotics
Measured: Time until discharge from recovery room, an expected average of 5 days
Treatment of anxiety
Treatment of anxiety is measured by anxiolytics
Measured: Time until discharge from recovery room, an expected average of 5 days
Treatment of sleep disorders
Treatment of sleep disorders are measured by sleeping drugs
Measured: Time until discharge from recovery room, an expected average of 5 days
Number of participants with changes in laboratory values
Routine laboratory results were planned to be documented in the hospital including hemoglobin, lymphocytes, total neutrophils, platelet count and white blood cell (WBC) count from blood samples.
Measured: Time until discharge from hospital, an expected average of 7 days
Apache II
APACHE II score is measured by the Acute Physiology and Chronic Health Evaluation System II.
Measured: Time until discharge from intensive care unit, an expected average of 6 days
SOFA
SOFA is measured by Sequential Organ Failure Assessment.
Measured: Time until discharge from intensive care unit, an expected average of 6 days
SAPS II
SAPS II is measured by Simplified Acute Physiology Score II.
Measured: Time until discharge from intensive care unit, an expected average of 6 days
Intensive care unit stay
Intensive care unit stay is measured in days
Measured: Time until discharge from intensive care unit, an expected average of 6 days
Hospital stay
Hospital stay is measured in days
Measured: Time until discharge from hospital, 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 posted10 Jun 2021
- Study start1 Oct 2021
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Why it stopped: Lack of equipment
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
- 5 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
- NCT04920734
- Sponsor's protocol ID
- CESARO-2
- Status last verified
- Feb 2025
- First submitted
- 4 Jun 2021
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of Therapy Options and Successes in the Long-term Course of Delirium in the Recovery Room - Multicenter Observational Study (CESARO-2)
- ClinicalTrials.gov ID
- NCT04920734
- Acronym / sponsor ID
- CESARO-2
- Conditions
- Delirium
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of equipment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 10 Jun 2021 (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.
This project is a multicenter pilot project to evaluate the therapeutic success in the long term up to 3 months after a delirium in a recovery room. There is a Europe-wide recommendation for the prevention of postoperative delirium in older patients and the evidence and consensus-based guideline "Management of delirium, analgesia and sedation in intensiv care medicine" of the AWMF (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften) are regularly updated for the detection and treatment of delirium in the intensive care unit. The aim is to evaluate the effects of a systematic delirium screening and the delirium treatment options in the long term in the same way as the current recommendations for the patient cohort of the recovery room.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the recovery room who have been diagnosed with delirium
Key inclusion criteria (5 listed)
- All patients admitted to the recovery room who have been diagnosed with delirium according to the treating physicians
- The patient is on a ward in the hospital
- Age ≥ 18 years
- Stay in the recovery room ≥ 1 day
- The patient is able to give consent
Key exclusion criteria (3 listed)
- Participation in a prospective intervention study (except adjuvant therapy study)
- Patients with underlying neurological diseases that make it difficult to differentiate from delirium
- Missing contact 3 months after stay in the recovery room.
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
Morbidity
Time frame: Up to three months
Postoperative complications according to Clavien-Dindo classification
22 secondary outcomes
Duration of delirium
Time frame: Time until discharge from recovery room, an expected average of 5 days
Incidence of delirium
Time frame: Time until discharge from recovery room, an expected average of 5 days
Preventive measures against delirium 1
Time frame: Time until discharge from recovery room, an expected average of 5 days
Preventive measures against delirium 2
Time frame: Time until discharge from recovery room, an expected average of 5 days
Anticholinergic drugs
Time frame: Time until discharge from hospital, an expected average of 7 days
Treatment of delirium
Time frame: Time until discharge from hospital, an expected average of 7 days
Measurement of acetylcholinesterase
Time frame: Time until discharge from recovery room, an expected average of 5 days
Measurement of butyrylcholinesterase
Time frame: Time until discharge from recovery room, an expected average of 5 days
Chronic comorbid diseases
Time frame: Time until discharge from hospital, an expected average of 7 days
Health related quality of life
Time frame: Up to three months
Treatment of vegetative symptoms
Time frame: Time until discharge from recovery room, an expected average of 5 days
Treatment of pain
Time frame: Time until discharge from recovery room, an expected average of 5 days
Treatment of postoperative vomiting
Time frame: Time until discharge from recovery room, an expected average of 5 days
Treatment of productive psychotic symptoms
Time frame: Time until discharge from recovery room, an expected average of 5 days
Treatment of anxiety
Time frame: Time until discharge from recovery room, an expected average of 5 days
Treatment of sleep disorders
Time frame: Time until discharge from recovery room, an expected average of 5 days
Number of participants with changes in laboratory values
Time frame: Time until discharge from hospital, an expected average of 7 days
Apache II
Time frame: Time until discharge from intensive care unit, an expected average of 6 days
SOFA
Time frame: Time until discharge from intensive care unit, an expected average of 6 days
SAPS II
Time frame: Time until discharge from intensive care unit, an expected average of 6 days
Intensive care unit stay
Time frame: Time until discharge from intensive care unit, an expected average of 6 days
Hospital stay
Time frame: Time until discharge from hospital, an expected average of 7 days
Results and safety
The study was stopped early (reason given: Lack of equipment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: No
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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 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: stopped early, as of the sponsor's last update on 24 Feb 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: Lack of equipment). 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?
Morbidity (time frame: Up to three months). 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 24 Feb 2025.