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

NCT04920734 | Terminated

• 1 other identifier: CESARO-2
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

• Morbidity

  Postoperative complications according to Clavien-Dindo classification

  Up to three months

Secondary Outcomes (22)

• Duration of delirium

  Time until discharge from recovery room, an expected average of 5 days

• Incidence of delirium

  Time until discharge from recovery room, an expected average of 5 days

• Preventive measures against delirium 1

  Time until discharge from recovery room, an expected average of 5 days

• Preventive measures against delirium 2

  Time until discharge from recovery room, an expected average of 5 days

• Anticholinergic drugs

  Time until discharge from hospital, an expected average of 7 days

Other Outcomes (1)

• Patient-specific characteristics

  At the beginning of the investigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients admitted to the recovery room who have been diagnosed with delirium

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Claudia Spies, MD, Prof.

  Charite University, Berlin, Germany

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.- Prof. Dr. C. Spies

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 10, 2021
• Study Start: October 1, 2021
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)