Predictive Factors and Complications of Delirium

Incidence, Predictive Factors and Complications of Delirium in Postoperative Cardiac Surgery Elderly Patients

The objective of this research was to determine the incidence, predisposing and triggering factors of delirium following cardiac surgery and its consequences within 30 days of surgery and during a 12-18-month follow-up in older adult patients.

Study Overview

• Status: Completed
• Conditions: Delirium; Surgery--Complications; Age Problem
• Intervention / Treatment: Procedure: Cardiac surgery

Detailed Description

Delirium is a transient and fluctuating course syndrome of acute onset that is characterized by reduced level of consciousness, global cognitive dysfunction, and disorder in the sleep-wake cycle. In patients undergoing cardiac surgery, delirium is a complication that affects 2-57% of the patients, reaching as high as 73% in older subjects.

The identification of patients at high risk for delirium is important to deliver proper care and avoid the consequences of this complication. However, previous studies published on the subject have not delivered definitive results in the cardiac surgery setting. Low educational level has also been studied as a risk factor for delirium after surgery but never in a group of cardiac surgery patients that includes a significant rate of illiteracy.

The objective of this research was to determine the incidence, predisposing and triggering factors of delirium following cardiac surgery and its consequences within 30 days of surgery and during a 12-18-month follow-up in older adult patients.

• Study Type: Observational
• Enrollment (Actual): 173

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients submitted to perioperative evaluation for elective cardiac surgery at the hospital de Messejana in Fortaleza, Ceara.

Description

Inclusion Criteria:

• Elective cardiovascular surgery

Exclusion Criteria:

• Blindness,
• deafness,
• previous stroke
• dementia
• delirium at inclusion, preoperatively
• creatinine clearance < 30 ml/min
• emergency surgery

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delirium	Delirium was assessed using the Confusion Assessment Method for the Intensive Care Unit	Until hospital discharge or 30 days after surgery, and for up to 18 months.

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: Hospital de Messejana

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2011
• Primary Completion (Actual): December 30, 2013
• Study Completion (Actual): June 30, 2015

Study Registration Dates

• First Submitted: August 7, 2017
• First Submitted That Met QC Criteria: August 9, 2017
• First Posted (Actual): August 11, 2017

Study Record Updates

• Last Update Posted (Actual): March 26, 2019
• Last Update Submitted That Met QC Criteria: March 23, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: 825/11

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