Increasing Preoperative Cognitive Reserve to Prevent Postoperative Cognitive Dysfunction in Cardiac Surgical Patients

NCT04493996 | Recruiting

• 1 other identifier: 48/20
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative delirium (POD) and postoperative cognitive decline (POCD) can be observed after cardiosurgical interventions. Taken together, these postoperative neurocognitive dysfunctions contribute to increased morbidity and mortality and higher economic costs. Preoperative risk factors of postoperative neurocognitive dysfunctions, such as decreased neuropsychometric performance or decreased cognitive daily activities, can be interpreted as reduced cognitive reserve. The aim of this study is to build up cognitive reserves to protect against the development of POD and POCD through preoperative, home-based, cognitive training.

Conditions

Postoperative Cognitive Decline; Postoperative Delirium; Postoperative Cognitive Dysfunction

Keywords

Cardiac Surgery; Postoperative Cognitive Decline; Postoperative Delirium; Cognitive Training; Cognitive Reserve; Postoperative Cognitive Dysfunction

Outcome Measures

Primary Outcomes (4)

• Number of participants with postoperative cognitive decline at 3 months after surgery, defined as a decrease between pre- and postoperative examinations of one standard deviation in at least 20% of all objective neuropsychological parameters

  The objective neuropsychological parameters measure cognitive domains like Immediate memory span, free recall, recognition memory, selective attention, working memory, inhibition and word fluency. These cognitive domains will be measured with the following instruments: "Verbaler Lern- und Merkfähigkeitstest" (VLMT), "Brief Visuospatial Memory Test-Revised" (BVMT-R), "Trail Making Test A/B" (TMT), "Letter Number Span Test" (LNS), "Regensburger Wortflüssigkeits-Test" (RWT), and "Syndrom-Kurz Test" (SKT-7).

  Immediately pre-training to 3 month post-surgery

• Number of participants with postoperative cognitive decline at the time of discharge from the acute clinic, defined as a decrease between the pre- and postoperative examinations of one standard deviation measured with the "Montreal Cognitive Assessment"

  The "Montreal Cognitive Assessment" (MOCA) is a screening procedure for general cognitive function.

  Immediately pre-training to approximately 1 week post-surgery

• Number of participants with postoperative delirium during the stay in the intensive care unit as assessed using the "Intensive Care Delirium Screening Checklist" (ICDSC)

  Postoperative delirium is defined as the occurrence of at least one delirious episode during a stay in the intensive care unit. The "Intensive Care Delirium Screening Checklist" (ICDSC) record the clinical symptoms of consciousness, attention, orientation, hallucinations, psychomotor retardation or agitation, speech, and changing symptoms by observing behavior and asking concrete questions to the patient.

  Immediately post-surgery to approximately 1-2 days post-surgery

• Number of participants with postoperative delirium during the stay on normal ward as assessed using the "Confusion Assessment Method" (3D-CAM)

  Postoperative delirium is defined as the occurrence of at least one delirious episode during a stay in an intensive care unit or normal ward. The "Confusion Assessment Method" (3D-CAM) record the clinical symptoms of consciousness, attention, orientation, hallucinations, psychomotor retardation or agitation, speech, and changing symptoms by observing behavior and asking concrete questions to the patient.

  Approximately 1 week (Immediately post-intensive care unit to approximately 1 week post-intensive care unit)

Secondary Outcomes (13)

• Change from baseline cognitive failures in everyday life at 3 months after surgery as assessed using the "Cognitive Failures Questionnaire" (CFQ)

  Immediately pre-training to 3 month post-surgery

• Change from baseline health-related quality of life at 3 months after surgery as assessed using the "36-Item Short Form Health Survey" (SF36)

  Immediately pre-training to 3 month post-surgery

• Change from baseline visual immediate memory span at the end of cognitive training as assessed using the "Brief Visuospatial Memory Test-Revised" (BVMT-R)

  Immediately pre-training to approximately 2-3 weeks post-training

• Change from baseline visual free recall at the end of cognitive training as assessed using the "Brief Visuospatial Memory Test-Revised" (BVMT-R)

  Immediately pre-training to approximately 2-3 weeks post-training

• Change from baseline visual recognition memory at the end of cognitive training as assessed using the "Brief Visuospatial Memory Test-Revised" (BVMT-R)

  Immediately pre-training to approximately 2-3 weeks post-training

Study Arms (2)

Cognitive training group

EXPERIMENTAL

Behavioral: Cognitive training

Control group

NO INTERVENTION

Interventions

Cognitive training BEHAVIORAL

The cognitive training involves a standardized, paper-and-pencil-based cognitive training that will be performed by the patients at home for approximately 40 minutes per day over a preoperative period of 2-3 weeks

Cognitive training group

Eligibility Criteria

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

You may qualify if:

• Elective cardiac surgery (coronary artery bypass surgery, aortic or mitral valve replacement/reconstruction, or combination surgery) with standardized extracorporeal circulation
• A sufficiently good knowledge of German is necessary as cognitive training and neuropsychological tests are language-dependent

You may not qualify if:

• History of stroke and preexisting psychiatric or neurological disorders that may impair the neuropsychological performance

Sponsors & Collaborators

• Heart and Brain Research Group, Germany: lead

Study Sites (1)

Department of Cardiac Surgery, Kerckhoff-Klinik GmbH

Bad Nauheim, 61231, Germany

RECRUITING

MeSH Terms

Conditions

Postoperative Cognitive Complications; Emergence Delirium

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Marius Butz, Dipl.-Psych.

  Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim

  PRINCIPAL INVESTIGATOR

• Martin Jünemann, Dr.med,M.Sc.

  Clinic for Neurology, University Hospital Gießen

  PRINCIPAL INVESTIGATOR

• Tibo Gerriets, Prof.Dr.med.

  Department of Neurology, Gesundheitszentrum Wetterau

  PRINCIPAL INVESTIGATOR

• Markus Schönburg, Prof.Dr.med.

  Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marius Butz, Dipl.-Psych.

CONTACT

+496032 996 5812; m.butz@kerckhoff-klinik.de

Martin Jünemann, Dr.med,M.Sc.

CONTACT

+49641 98558917; Martin.Juenemann@neuro.med.uni-giessen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 31, 2020
• Study Start: August 14, 2020
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

DE (1)