Predictive Factors and Complications of Delirium

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03246165
• Other study ID #: 825/11
• Status: Completed
• Start date: September 1, 2011
• Est. completion date: June 30, 2015

Study information

• Verified date: March 2019
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: June 30, 2015
• Est. primary completion date: December 30, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Elective cardiovascular surgery

Exclusion Criteria:

• Blindness,

• deafness,

• previous stroke

• dementia

• delirium at inclusion, preoperatively

• creatinine clearance < 30 ml/min

• emergency surgery

Related Conditions & MeSH terms

• Age Problem
• Delirium
• Surgery--Complications

Intervention

Procedure:
• Cardiac surgery
Coronary bypass, heart valve replacement

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Hospital de Messejana

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.