Accompanying Scientific Program for the Quality Contract Prevention of Postoperative Delirium in the Care of Older Patients (WB-QC-POD)

NCT05847010 | Recruiting

• 1 other identifier: WB-QC-POD
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In the course of a scientific accompanying program, the project pursues the goal of gaining further insight into a possible connection between various influencing factors and the development of postoperative delirium. Against this background, in addition to the primary goal of exploring delirium rates, we aim to identify associations between other secondary end goals like the internal circadian time or the heart rate variability and the occurrence of postoperative delirium. For this purpose, patients of the QC-POD (NCT04355195) sample will be studied.

Conditions

Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative Delirium

  Incidence of postoperative delirium in all postoperative patients in normal ward, intensive care unit and recovery room with a validated delirium screening tool at two points in time.

  Up to the fifth postoperative day

Secondary Outcomes (12)

• Duration of Delirium

  The participants are followed up until the end of hospital stay, an expected average of 7 days

• Bodytime

  Before surgery

• Chronotype 1

  Up to three months

• Chronotype 2

  Up to three months

• Heart rate variability 1

  The participants are followed up until the end of hospital stay, an expected average of 7 days.

Other Outcomes (3)

• Proteomics

  At the morning of surgery

• Metabolomics

  At the morning of surgery

• Bodytime

  At the morning of surgery

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged ≥70 years, male and female, who are receiving surgery

You may qualify if:

• Age ≥ 70 years
• Male and female patients
• Patients who have been included in QC-POD
• surgery (elective and not elective)

You may not qualify if:

• Moribund patients (palliative situation)
• Insufficient knowledge of the German language
• Cardiac arrhythmia (e.g. atrial fibrillation)
• Presence of a pacemaker
• Condition after heart transplantation
• Inflammation in the area of the frontal sinus

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Department of Anaesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum (CVK) and Campus Charite Mitte (CCM), Charite - Universitätsmedizin Berlin

Berlin, 13353, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples (monocytes and Cholinesterase activity)

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Claudia Spies, MD, Prof.

  Charite University, Berlin, Germany

  STUDY DIRECTOR

Central Study Contacts

Claudia Spies, MD, Prof.

CONTACT

+49 30 450 55 11 02; claudia.spies@charite.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Anesthesiolgy and Intensive Care Medicine CC07

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: May 6, 2023
• Study Start: June 22, 2023
• Primary Completion: July 1, 2025
• Study Completion: September 1, 2025
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)