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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04920734
Enrollment
5
Registered
2021-06-10
Start date
2021-10-01
Completion date
2022-03-30
Last updated
2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

None listed

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
MorbidityUp to three monthsPostoperative complications according to Clavien-Dindo classification

Secondary

MeasureTime frameDescription
Treatment of painTime until discharge from recovery room, an expected average of 5 daysTreatment of pain is measured by analgesia
Duration of deliriumTime until discharge from recovery room, an expected average of 5 daysDuration of delirium is measured in days
Incidence of deliriumTime until discharge from recovery room, an expected average of 5 daysPostoperative 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 postoperative vomitingTime until discharge from recovery room, an expected average of 5 daysTreatment of postoperative vomiting is measured by anti-emetics
Preventive measures against delirium 1Time until discharge from recovery room, an expected average of 5 daysPreventive measures of delirium are measured by medical treatments
Preventive measures against delirium 2Time until discharge from recovery room, an expected average of 5 daysPreventive measures of delirium are measured by non-medical treatments
Anticholinergic drugsTime until discharge from hospital, an expected average of 7 daysMeasured by anticholinergic drug scale
Treatment of deliriumTime until discharge from hospital, an expected average of 7 daysTreatment of delirium with medication
Measurement of acetylcholinesteraseTime until discharge from recovery room, an expected average of 5 daysMeasurement of activities of the enzyme - acetylcholinesterase in blood
Measurement of butyrylcholinesteraseTime until discharge from recovery room, an expected average of 5 daysMeasurement of activities of the enzyme - butyrylcholinesterase in blood
Chronic comorbid diseasesTime until discharge from hospital, an expected average of 7 daysChronic comorbid diseases (comorbidities) are measured by Charlson comorbidity index
Treatment of vegetative symptomsTime until discharge from recovery room, an expected average of 5 daysTreatment of vegetative symptoms is measured by vegetative medical therapy
Treatment of productive psychotic symptomsTime until discharge from recovery room, an expected average of 5 daysTreatment of productive psychotic symptoms is measured by anti-psychotics
Treatment of anxietyTime until discharge from recovery room, an expected average of 5 daysTreatment of anxiety is measured by anxiolytics
Treatment of sleep disordersTime until discharge from recovery room, an expected average of 5 daysTreatment of sleep disorders are measured by sleeping drugs
Number of participants with changes in laboratory valuesTime until discharge from hospital, an expected average of 7 daysRoutine 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.
Apache IITime until discharge from intensive care unit, an expected average of 6 daysAPACHE II score is measured by the Acute Physiology and Chronic Health Evaluation System II.
SOFATime until discharge from intensive care unit, an expected average of 6 daysSOFA is measured by Sequential Organ Failure Assessment.
SAPS IITime until discharge from intensive care unit, an expected average of 6 daysSAPS II is measured by Simplified Acute Physiology Score II.
Intensive care unit stayTime until discharge from intensive care unit, an expected average of 6 daysIntensive care unit stay is measured in days
Hospital stayTime until discharge from hospital, an expected average of 7 daysHospital stay is measured in days
Health related quality of lifeUp to three monthsEQ-5D

Other

MeasureTime frameDescription
Patient-specific characteristicsAt the beginning of the investigationPatient-specific characteristics are measured by demographic data

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026