Clinical trial NCT04920734: Description of Therapy Options and Successes in the Long-term Course of Delirium in the Recovery Room - CESARO II
Official title: Description of Therapy Options and Successes in the Long-term Course of Delirium in the Recovery Room - Multicenter Observational Study (CESARO-2)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Delirium
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients admitted to the recovery room who have been diagnosed with delirium

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Morbidity
timeFrame: Up to three months
Secondary outcomes:
measure: Duration of delirium
timeFrame: Time until discharge from recovery room, an expected average of 5 days
measure: Incidence of delirium
timeFrame: Time until discharge from recovery room, an expected average of 5 days
measure: Preventive measures against delirium 1
timeFrame: Time until discharge from recovery room, an expected average of 5 days
measure: Preventive measures against delirium 2
timeFrame: Time until discharge from recovery room, an expected average of 5 days
measure: Anticholinergic drugs
timeFrame: Time until discharge from hospital, an expected average of 7 days
measure: Treatment of delirium
timeFrame: Time until discharge from hospital, an expected average of 7 days
measure: Measurement of acetylcholinesterase
timeFrame: Time until discharge from recovery room, an expected average of 5 days
measure: Measurement of butyrylcholinesterase
timeFrame: Time until discharge from recovery room, an expected average of 5 days
measure: Chronic comorbid diseases
timeFrame: Time until discharge from hospital, an expected average of 7 days
measure: Health related quality of life
timeFrame: Up to three months
measure: Treatment of vegetative symptoms
timeFrame: Time until discharge from recovery room, an expected average of 5 days
measure: Treatment of pain
timeFrame: Time until discharge from recovery room, an expected average of 5 days
measure: Treatment of postoperative vomiting
timeFrame: Time until discharge from recovery room, an expected average of 5 days
measure: Treatment of productive psychotic symptoms
timeFrame: Time until discharge from recovery room, an expected average of 5 days
measure: Treatment of anxiety
timeFrame: Time until discharge from recovery room, an expected average of 5 days
measure: Treatment of sleep disorders
timeFrame: Time until discharge from recovery room, an expected average of 5 days
measure: Number of participants with changes in laboratory values
timeFrame: Time until discharge from hospital, an expected average of 7 days
measure: Apache II
timeFrame: Time until discharge from intensive care unit, an expected average of 6 days
measure: SOFA
timeFrame: Time until discharge from intensive care unit, an expected average of 6 days
measure: SAPS II
timeFrame: Time until discharge from intensive care unit, an expected average of 6 days
measure: Intensive care unit stay
timeFrame: Time until discharge from intensive care unit, an expected average of 6 days
measure: Hospital stay
timeFrame: Time until discharge from hospital, an expected average of 7 days
Other outcomes:
measure: Patient-specific characteristics
timeFrame: At the beginning of the investigation
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References: