Trials / Completed
CompletedNCT02210312
Study of Depressive Symptoms Predicting Postoperative Cognitive Dysfunction
Are Preoperative Depressive Symptoms Predictive for Postoperative Dysfunction in Non-cardiac Surgery?
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (actual)
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf · Academic / Other
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Accepted
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.
Conditions
Timeline
- Start date
- 2014-05-01
- Primary completion
- 2018-07-01
- Completion
- 2018-10-01
- First posted
- 2014-08-06
- Last updated
- 2019-04-30
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT02210312. Inclusion in this directory is not an endorsement.