Study of Depressive Symptoms Predicting Postoperative Cognitive Dysfunction

Completed

• Conditions: Postoperative Delirium; Postoperative Cognitive Dysfunction; Depressive Symptoms

• Registration Number: NCT02210312
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

Postoperative cognitive dysfunction (POCD) describes a condition where cognitive functions such as attention, perception, concentration, learning, abstract thinking and problem solving are impaired postoperatively. These changes can be resolved after weeks and months. In some cases, changes are permanent.

Detailed Description

The aetiology of POCD is multifactorial. One described risk factor is preoperative existing depressive symptoms in patients undergoing cardiac surgery.

A total of 300 consecutive patients and 80 healthy controls will be enrolled in this study. Patients will be followed up at 7 days, 3 months and 1 year postoperatively. The co gnitive function will be tested and compared to tests done before surgery. Postoperatively - from the day of operation until the 7th day (except day 6) - grade of sedation, agitation, signs of delirium, pain, cardiac, respiratory, renal and infectious complications will be monitored.

Next to preoperative depressive symptoms we will also evaluate a diagnosed depression, anxiety, pain, health-related quality of life, physical comorbidities, adrenal cortical insufficiency, type of anaesthesia, intraoperative blood loss, organ complications, postoperative delirium, baseline cognitive functioning and the number of operations/anaesthetics in the study period after the initial operation as further potential predictors of POCD.

In addition, laboratory values and certain medications will be documented. These include: anaemia, hypercalcaemia, thyroidal gland hormones, electrolytes, creatinine, urea, glomerular filtration rate and cortisone therapy.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-06-16
• Study First Submitted QC: 2014-08-04
• Study First Posted: 2014-08-06
• Primary Completion: 2018-07
• Study Completion: 2018-10
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-28
• Last Update Posted: 2019-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of occurrence of intermediate POCD	3 months	POCD is measured by use of a neuropsychological test battery comprising the following subtests: Alertness, Go/Nogo, and Incompatibility from the TAP 2.3 (attention), Trail Making Test A and B (attention), Digit span (memory), Verbal Learning and Memory Test (memory), Regensburg Word Fluency Test (executive function)
Frequency of occurrence of early POCD	7 days	POCD is measured by use of a neuropsychological test battery comprising the following subtests: Alertness, Go/Nogo, and Incompatibility from the TAP 2.3 (attention), Trail Making Test A and B (attention), Digit span (memory), Verbal Learning and Memory Test (memory), Regensburg Word Fluency Test (executive function)
Frequency of occurrence of late POCD	1 year	POCD is measured by use of a neuropsychological test battery comprising the following subtests: Alertness, Go/Nogo, and Incompatibility from the TAP 2.3 (attention), Trail Making Test A and B (attention), Digit span (memory), Verbal Learning and Memory Test (memory), Regensburg Word Fluency Test (executive function)

Secondary Outcome Measures

Name	Time	Method
Frequency of occurrence of postoperative delirium	7th postoperative day	measured twice per day: Confusion Assessment Method (CAM-ICU) and Richmond Agitation and Sedation Scale (RASS)
Rate of organ complications (cardiac, respiratory, renal)	day of operation until 7th postoperative day
Mortality	1 year
Hospital length of stay	day of admission until day of discharge, up to 24 weeks
Health related quality of life	7 days, 3 months, 1 year after operation	Time Frame: 7 days after operation \[Measure: Short Form-12 Health Survey: Item General Health\] Time Frame: 3 months after operation \[Measure: Short Form-12 Health Survey: Physical and mental health summary measures\] Time Frame: 1 year after operation \[Measure: Short Form-12 Health Survey: Physical and mental health summary measures\]

Trial Locations

Locations (1)

Department of Anaesthesiology and Intensive Care Medicine, University Hospital Hamburg Eppendorf, Univ.-Prof. Dr. med. Alwin E. Goetz and Prof. Dr. med. Christian Zoellner; 🇩🇪 Hamburg, Germany