Risk Factor of POD and POCD After Cardiac Surgery

Active, not recruiting

• Conditions: Postoperative Cognitive Dysfunction; Postoperative Delirium

• Registration Number: NCT03635229
• Lead Sponsor: Mahidol University

Brief Summary

Postoperative delirium (POD) and postoperative cognitive decline (POCD) are common after surgeries in the elderly, especially after cardiothoracic surgery. These conditions are associated with adverse short- and long-term outcomes.

Multiple conditions in the perioperative period have been proposed as risk factors of POD and POCD.

Incidences vary across institutions due to differences in screening and diagnostic tools.

Detailed Description

This is a prospective observational study to identify the incidences and risk factors of postoperative delirium and postoperative cognitive decline after elderly patients undergoing cardiac surgical procedures which require cardiopulmonary bypass and postoperative intensive care unit (ICU) admission.

Patients will be screen for POD and POCD with various psychological tests in the postoperative period and after hospital discharge.

Perioperative data and outcomes will be used to identify risk factors of both conditions.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-08-15
• Study First Submitted QC: 2018-08-15
• Study First Posted: 2018-08-17
• Study Start: 2018-08-21
• Primary Completion: 2023-09-26
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-20
• Last Update Posted: 2023-10-23
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• age 65 years old or older
• undergoing open heart surgery (cardiopulmonary bypass assisted cardiothoracic surgery

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Exclusion Criteria

• unable to communicate
• severe visual or hearing impairment

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative delirium	Postoperative day 1-5 (5 consecutive days)	A result consistent with postoperative delirium by using Confusion Assessment Method-ICU (CAM-ICU) in the postoperative period

Secondary Outcome Measures

Name	Time	Method
Postoperative cognitive dysfunction - postoperative	Postoperative day 5-9 (5 consecutive days)	A result consistent with postoperative cognitive dysfunction by using Montreal Cognitive Assessment (MOCA)
Postoperative cognitive dysfunction - 3 month	At 3rd month after hospital discharge	A result consistent with postoperative cognitive dysfunction by using Montreal Cognitive Assessment (MOCA)
Postoperative cognitive dysfunction - 1 year	At 12th month after hospital discharge	A result consistent with postoperative cognitive dysfunction by using Montreal Cognitive Assessment (MOCA)

Trial Locations

Locations (1)

Siriraj Hospital; 🇹🇭 Bangkok, Thailand