Description of Therapy Options and Successes in the Long-term Course of Delirium in the Recovery Room - CESARO II

Delirium Clinical Trial

Official title:

Description of Therapy Options and Successes in the Long-term Course of Delirium in the Recovery Room - Multicenter Observational Study (CESARO-2)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04920734
• Other study ID #: CESARO-2
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: June 2023

Study information

• Verified date: October 2021
• Source: Charite University, Berlin, Germany
• Contact: Claudia Spies, MD, Prof.
• Phone: +49 30 450 55 11 02
• Email: claudia.spies[@]charite.de
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient-specific characteristics	Patient-specific characteristics are measured by demographic data	At the beginning of the investigation
Primary	Morbidity	Postoperative complications according to Clavien-Dindo classification	Up to three months
Secondary	Duration of delirium	Duration of delirium is measured in days	Time until discharge from recovery room, an expected average of 5 days
Secondary	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.	Time until discharge from recovery room, an expected average of 5 days
Secondary	Preventive measures against delirium 1	Preventive measures of delirium are measured by medical treatments	Time until discharge from recovery room, an expected average of 5 days
Secondary	Preventive measures against delirium 2	Preventive measures of delirium are measured by non-medical treatments	Time until discharge from recovery room, an expected average of 5 days
Secondary	Anticholinergic drugs	Measured by anticholinergic drug scale	Time until discharge from hospital, an expected average of 7 days
Secondary	Treatment of delirium	Treatment of delirium with medication	Time until discharge from hospital, an expected average of 7 days
Secondary	Measurement of acetylcholinesterase	Measurement of activities of the enzyme - acetylcholinesterase in blood	Time until discharge from recovery room, an expected average of 5 days
Secondary	Measurement of butyrylcholinesterase	Measurement of activities of the enzyme - butyrylcholinesterase in blood	Time until discharge from recovery room, an expected average of 5 days
Secondary	Chronic comorbid diseases	Chronic comorbid diseases (comorbidities) are measured by Charlson comorbidity index	Time until discharge from hospital, an expected average of 7 days
Secondary	Health related quality of life	EQ-5D	Up to three months
Secondary	Treatment of vegetative symptoms	Treatment of vegetative symptoms is measured by vegetative medical therapy	Time until discharge from recovery room, an expected average of 5 days
Secondary	Treatment of pain	Treatment of pain is measured by analgesia	Time until discharge from recovery room, an expected average of 5 days
Secondary	Treatment of postoperative vomiting	Treatment of postoperative vomiting is measured by anti-emetics	Time until discharge from recovery room, an expected average of 5 days
Secondary	Treatment of productive psychotic symptoms	Treatment of productive psychotic symptoms is measured by anti-psychotics	Time until discharge from recovery room, an expected average of 5 days
Secondary	Treatment of anxiety	Treatment of anxiety is measured by anxiolytics	Time until discharge from recovery room, an expected average of 5 days
Secondary	Treatment of sleep disorders	Treatment of sleep disorders are measured by sleeping drugs	Time until discharge from recovery room, an expected average of 5 days
Secondary	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.	Time until discharge from hospital, an expected average of 7 days
Secondary	Apache II	APACHE II score is measured by the Acute Physiology and Chronic Health Evaluation System II.	Time until discharge from intensive care unit, an expected average of 6 days
Secondary	SOFA	SOFA is measured by Sequential Organ Failure Assessment.	Time until discharge from intensive care unit, an expected average of 6 days
Secondary	SAPS II	SAPS II is measured by Simplified Acute Physiology Score II.	Time until discharge from intensive care unit, an expected average of 6 days
Secondary	Intensive care unit stay	Intensive care unit stay is measured in days	Time until discharge from intensive care unit, an expected average of 6 days
Secondary	Hospital stay	Hospital stay is measured in days	Time until discharge from hospital, an expected average of 7 days