Older People's Neurocognitive Recovery After Cardiac Surgery

NCT06469515 | Recruiting

• 1 other identifier: 2023-02089
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

Society is aging and advantages in anesthesia and surgery allow more complex interventions in older persons. Old age is a significant risk factor for the development of postoperative neurocognitive decline characterized by a gradual decrease in performance in several cognitive domains such as memory, attention, information processing, and executive functions, leading to problems with performing daily activities and maintaining independence and postoperative complications. The purpose of this study is to measure older persons' postoperative neurocognitive function, to detect neurocognitive decline, and to identify risk factors and difficulties in daily living as well as explore close relatives' experiences of it. We will include 220 participants ≥65 years of age undergoing planned cardiac surgery. Cognitive symptoms and signs and neurocognitive function will be assessed up to 6 months after surgery. Risk/affected factors such as delirium, functional status, recovery, depression, and healthcare-related quality of life, as well as close relative's experiences and burden, will be measured. The results will have immediate relevance for a substantial number of older persons undergoing surgery, and their close relatives, by enhancing knowledge about postoperative cognitive decline and recovery, and subsequently identifying what support needs to be implemented.

Conditions

Postoperative Cognitive Dysfunction; Postoperative Recovery; Cardiac Surgery

Outcome Measures

Primary Outcomes (5)

• Postoperative cognitive complaints

  The Swedish Quality of Recovery cognitive version (SwQoR-Cog) is a self-assessment questionnaire that measures postoperative symptoms. The form consists of 14 statements regarding symptoms and discomforts, of which 11 address cognitive symptoms and 3 are related to pain and nausea. Symptoms and discomforts are rated on an 11-point scale (0=not at all to 10=all the time).

  Before surgery and weekly up to three months after surgery

• Changes in postoperative cognitive function, part 1

  Consortium to Establish a Registry for Alzheimer´s Disease (CERAD) A 10-word verbal learning test with 3 learning trials, a recall trial after \~7 min.

  Before surgery and 1, 3, and 6 months after surgery

• Changes in postoperative cognitive function, part 2

  Trail Making Test (TMT- A \& B) consists of 25 circles with letters or numbers on the screen.

  Before surgery and 1, 3, and 6 months after surgery

• Changes in postoperative cognitive function, part 3

  Stroop Colour-Word Test (SCW). 24 words spelling out the name of a colour which is printed in contrasting ink colours (e.g., the word "green" printed with red ink), and the participant is asked to tell the printed colour of the word rather than the word rather than the actual meaning of the word.

  Before surgery and 1, 3, and 6 months after surgery

• Changes in postoperative cognitive function, part 4

  Symbol Digits Processing Test (SDPT). The test consists of nine symbol-digit pairings at the top of the screen, one symbol in the middle of the screen, and a number grid at the bottom.

  Before surgery and 1, 3, and 6 months after surgery

Secondary Outcomes (12)

• Postoperative delirium

  Twice daily up to postoperative day 7

• Perceived self-efficacy

  Before surgery and 1, 3, and 6 months after surgery

• Depressive symtoms

  Before surgery and 1, 3, and 6 months after surgery

• Functional activity

  Before surgery and 1, 3, and 6 months after surgery

• Frailty

  Before surgery and at 6 months after surgery

Other Outcomes (1)

• Demographic and perioperative data

  At baseline and perioperatively

Interventions

Elective or urgent cardiac surgery OTHER

This is a longitudinal observational study to explore postoperative cognitive recovery among older persons (aged 65 or older) undergoing elective or urgent cardiac surgery via sternotomy.

Eligibility Criteria

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

Study Population

The study population consists of patients (65 years or older) who have undergone cardiac surgery and their relatives. The study participant is qualified for inclusion if he or she meets all the inclusion criteria and none of the exclusion criteria.

You may qualify if:

• Scheduled for elective or urgent open-heart surgery or minimally invasive cardiac surgery
• Resident in the area/region for the current thoracic clinic
• Able to read and understand Swedish

You may not qualify if:

• Physical, mental, and cognitive difficulties that prevent the individual from completing the cognitive tests
• Undergone surgery within the last 6 months

Sponsors & Collaborators

• Karolinska Institutet: lead
• Sahlgrenska University Hospital: collaborator

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Sweden

RECRUITING

Related Publications (1)

• Bergman L, Zecevic E, Damen T, Markovic G, Martinik A, Saarijarvi M, Eckerblad J, Nilsson U. Exploring cognitive function and postoperative neurocognitive recovery after cardiac surgery in older adults (ECPON): a protocol for an observational study. BMJ Open. 2025 Jun 22;15(6):e098208. doi: 10.1136/bmjopen-2024-098208.

  PMID: 40545303 DERIVED

MeSH Terms

Conditions

Postoperative Cognitive Complications

Interventions

Elective Surgical Procedures

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Central Study Contacts

Lina Bergman, PhD

CONTACT

0046 8 524 836 66; lina.bergman@ki.se

Ulrica Nilsson, Professor

CONTACT

ulica.nilsson@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 21, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 7, 2024

Record last verified: 2024-11

Locations

SE (1)