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Clinical Trials/NCT03635229
NCT03635229
Active, Not Recruiting
N/A

Risk Factor of Postoperative Delirium and Postoperative Cognitive Decline After Cardiac Surgery

Mahidol University1 site in 1 country360 target enrollmentAugust 21, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Postoperative Delirium
Sponsor
Mahidol University
Enrollment
360
Locations
1
Primary Endpoint
Postoperative delirium
Status
Active, Not Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 21, 2018
End Date
December 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Postoperative delirium

Time Frame: 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 Outcomes

  • Postoperative cognitive dysfunction - postoperative(Postoperative day 5-9 (5 consecutive days))
  • Postoperative cognitive dysfunction - 3 month(At 3rd month after hospital discharge)
  • Postoperative cognitive dysfunction - 1 year(At 12th month after hospital discharge)

Study Sites (1)

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