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NCT Number: NCT03246165

Predictive Factors and Complications of Delirium

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.

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Key information

Conditions

Delirium Age Problem Confusion Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Surgery--Complications

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elective cardiovascular surgery

Exclusion criteria

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

Treatment and study plan

cardiac surgery

Procedure

Coronary bypass, heart valve replacement

Primary outcomes

  1. Delirium

    Time frame: Until hospital discharge or 30 days after surgery, and for up to 18 months.

    Delirium was assessed using the Confusion Assessment Method for the Intensive Care Unit

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Hospital de Messejana

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2015
First posted
Aug 11, 2017
Registry last updated
Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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