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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03246165
Other study ID # 825/11
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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