Description of Therapy Options and Successes in the Long-term Course of Delirium in the Recovery Room - CESARO II
- Conditions
- Delirium
- Registration Number
- NCT04920734
- Lead Sponsor
- Charite University, Berlin, Germany
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
- 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
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Morbidity Up to three months Postoperative complications according to Clavien-Dindo classification
- Secondary Outcome Measures
Name Time Method Measurement of butyrylcholinesterase Time until discharge from recovery room, an expected average of 5 days Measurement of activities of the enzyme - butyrylcholinesterase in blood
Treatment of vegetative symptoms Time until discharge from recovery room, an expected average of 5 days Treatment of vegetative symptoms is measured by vegetative medical therapy
Treatment of postoperative vomiting Time until discharge from recovery room, an expected average of 5 days Treatment of postoperative vomiting is measured by anti-emetics
Duration of delirium Time until discharge from recovery room, an expected average of 5 days Duration of delirium is measured in days
Preventive measures against delirium 1 Time until discharge from recovery room, an expected average of 5 days Preventive measures of delirium are measured by medical treatments
Preventive measures against delirium 2 Time until discharge from recovery room, an expected average of 5 days Preventive measures of delirium are measured by non-medical treatments
Chronic comorbid diseases Time until discharge from hospital, an expected average of 7 days Chronic comorbid diseases (comorbidities) are measured by Charlson comorbidity index
Treatment of pain Time until discharge from recovery room, an expected average of 5 days Treatment of pain is measured by analgesia
Treatment of productive psychotic symptoms Time until discharge from recovery room, an expected average of 5 days Treatment of productive psychotic symptoms is measured by anti-psychotics
Number of participants with changes in laboratory values Time until discharge from hospital, an expected average of 7 days 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.
Anticholinergic drugs Time until discharge from hospital, an expected average of 7 days Measured by anticholinergic drug scale
Health related quality of life Up to three months EQ-5D
Incidence of delirium Time until discharge from recovery room, an expected average of 5 days 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.
Treatment of delirium Time until discharge from hospital, an expected average of 7 days Treatment of delirium with medication
Measurement of acetylcholinesterase Time until discharge from recovery room, an expected average of 5 days Measurement of activities of the enzyme - acetylcholinesterase in blood
Treatment of sleep disorders Time until discharge from recovery room, an expected average of 5 days Treatment of sleep disorders are measured by sleeping drugs
SOFA Time until discharge from intensive care unit, an expected average of 6 days SOFA is measured by Sequential Organ Failure Assessment.
Intensive care unit stay Time until discharge from intensive care unit, an expected average of 6 days Intensive care unit stay is measured in days
Apache II Time until discharge from intensive care unit, an expected average of 6 days APACHE II score is measured by the Acute Physiology and Chronic Health Evaluation System II.
SAPS II Time until discharge from intensive care unit, an expected average of 6 days SAPS II is measured by Simplified Acute Physiology Score II.
Treatment of anxiety Time until discharge from recovery room, an expected average of 5 days Treatment of anxiety is measured by anxiolytics
Hospital stay Time until discharge from hospital, an expected average of 7 days Hospital stay is measured in days
Trial Locations
- Locations (1)
Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany