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NCT03635229 Clinical Trial

Risk Factor of POD and POCD After Cardiac Surgery

Postoperative Delirium Clinical Trial

Official title:
Risk Factor of Postoperative Delirium and Postoperative Cognitive Decline After Cardiac Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03635229
Other study ID # 705/2560(EC1)
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date August 21, 2018
Est. completion date December 2023

Study information
Verified date October 2023
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 360
Est. completion date December 2023
Est. primary completion date September 26, 2023
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - age 65 years old or older - undergoing open heart surgery (cardiopulmonary bypass assisted cardiothoracic surgery Exclusion Criteria: - unable to communicate - severe visual or hearing impairment

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Thailand Siriraj Hospital Bangkok

Sponsors (1)
Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative delirium A result consistent with postoperative delirium by using Confusion Assessment Method-ICU (CAM-ICU) in the postoperative period Postoperative day 1-5 (5 consecutive days)
Secondary Postoperative cognitive dysfunction - postoperative A result consistent with postoperative cognitive dysfunction by using Montreal Cognitive Assessment (MOCA) Postoperative day 5-9 (5 consecutive days)
Secondary Postoperative cognitive dysfunction - 3 month A result consistent with postoperative cognitive dysfunction by using Montreal Cognitive Assessment (MOCA) At 3rd month after hospital discharge
Secondary Postoperative cognitive dysfunction - 1 year A result consistent with postoperative cognitive dysfunction by using Montreal Cognitive Assessment (MOCA) At 12th month after hospital discharge
See also
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Active, not recruiting NCT03629262 - Dexmedetomidine Supplemented Intravenous Analgesia in Elderly After Orthopedic Surgery Phase 4
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Completed NCT01964274 - Relevance of the Peripheral Cholinesterase-activity on Neurocognitive Dysfunctions in Surgical Patients
Completed NCT01599689 - Pilot and Feasibility Study of a Mirrors Intervention for Reducing Delirium in Older Cardiac Surgical Patients N/A
Active, not recruiting NCT03291626 - Postoperative Delirium: EEG Markers of Sleep and Wakefulness