Risk Factor of POD and POCD After Cardiac Surgery

October 20, 2023 updated by: Mahidol University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

360

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Siriraj Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Elderly patients (age 65 and older) undergoing cardiopulmonary bypass- assisted surgery with anticipated postoperative intensive care unit admission

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Postoperative day 1-5 (5 consecutive days)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2018

Primary Completion (Actual)

September 26, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

August 15, 2018

First Submitted That Met QC Criteria

August 15, 2018

First Posted (Actual)

August 17, 2018

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 20, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 705/2560(EC1)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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