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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04920734
Other study ID # CESARO-2
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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