Predictors for Postoperative Delirium After Cardiac Surgery in Adults: a One-year, Single Center, Observational Cohort Study (PODCAS)

The Diagnostic and Statistical Manual of Mental Disorders, 5th ed. (DSM-5) describes delirium as a "disturbance in attention (i.e., reduced ability to direct, focus, sustain, and shift attention) and awareness (reduced orientation to the environment)". In addition, a "disturbance in cognition (e.g., memory deficit, disorientation, language, visuospatial ability, or perception)" occurs.

Postoperative delirium (POD) usually develops in connection with a surgical procedure within the first five days after an intervention. Roughly 10-70% of all surgical patients above the age of 65 years are affected.

POD places not only a burden to the patient and their families by increasing functional and cognitive damages, and increasing mortality, it also has a high impact on the health care resource utilization. A patient with POD often requires more intensive care, has a longer length of hospital stay, more complications, and often requires long-term care after being discharged from the hospital. All these aspects show the need for prevention of POD.

There are various preoperative risk factors that influence the development of POD. Broad research has been done on this topic and shown that advanced age, cognitive impairment, depression and other psychopathologic symptoms, intake of psychotropic substances, sensory impairment like decrease in visual or auditory perception, impairment in daily life activities, dehydration, malnutrition, metabolic dysfunctions, urinary catheters, severity of disease and different comorbidities, such as chronic cardiac insufficiency, atrial fibrillation, or previous history of stroke or infections may favor the occurrence of POD.

The incidence of POD is among the highest in cardiac surgery. The study was designed to assess predictors for POD after cardiac surgery. Study hypothesis is that some patient variables, scores and biomarkers are not only predictive of the incidence of POD but also of the severity of delirium-associated symptoms and duration of POD after cardiac surgery.

Study Overview

• Status: Completed
• Conditions: Postoperative Delirium
• Intervention / Treatment: Other: no intervention

• Study Type: Observational
• Enrollment (Actual): 656

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Study subjects are all patients who underwent cardiac surgery at the University Hospital Basel during the year 2013. Patients are identified by screening of the list of operative procedures of this year, made available by the Department of Cardiac Surgery at the University Hospital Basel.

Description

Inclusion Criteria:

All patients who underwent cardiac surgery with cardiopulmonary bypass at University Hospital Basel in 2013 were included.

Exclusion Criteria:

• Patients who died during the operation.
• Patients who lack the primary outcome measure.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cardiac surgery; Study subjects are all patients who underwent cardiac surgery with cardiopulmonary bypass at the University Hospital Basel during the year 2013.	Other: no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative delirium	Postoperative delirium diagnosed by the Intensive Care Delirium Screening Checklist (ICDSC)	Baseline value on postoperative day 1 and postoperative day 2 until discharge from the intensive care unit

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Nicolai Goettel, MD, University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): December 31, 2013
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: November 17, 2015
• First Submitted That Met QC Criteria: November 22, 2015
• First Posted (Estimate): November 25, 2015

Study Record Updates

• Last Update Posted (Actual): April 25, 2018
• Last Update Submitted That Met QC Criteria: April 24, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Cardiac surgery; Cardiopulmonary bypass; Postoperative delirium; Risk factor
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: PODCAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO