An observational study in Cognitive Impairment, Postoperative Delirium and Spine Fusion, sponsored by University Medicine Greifswald. Terminated at 1 site in Germany. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-27.
Sponsored by University Medicine Greifswald · Observational
Older people are a rapidly growing proportion of the world's population and their number is expected to increase twofold by 2050. When these people become patients that require surgery, they are at particular high risk for postoperative delirium (POD), which is associated with longer hospital stays, higher costs, risk for delayed complications and cognitive dysfunction (POCD). Having suffered an episode of delirium is furthermore a predictor of long-term care dependency. Despite these risks, an increasing number of elderly undergo major elective surgery. This is reflected by the frequency of elective spinal surgery, in general, and instrumented fusions, in particular, which has markedly increased over the past few decades.
It is yet insufficiently understood, which, particularly modifiable, factors contribute to the development of POD and POCD following these major but plannable surgeries. A better understanding of risk factors would facilitate informed patient decisions and surgical strategies could be tailored to individual risk profiles.
All patients seen in a neurosurgical oupatient clinic will be screened for eligibility.
Exclusion Criteria:
postoperative delirium - incidence
screening through Nu-DESC (Nursing Delirium Screening Scale) ≥ 2 and verification of screening procedure by DSM-V (Diagnostic and Statistical Manual of Mental Disorders 5th Edition) criteria once during each shift
Time frame: ≤ 3 days postoperatively
postoperative delirium - duration
screening through Nu-DESC ≥ 2 and verification of screening procedure by DSM-V criteria DSM-V once during each shift
Time frame: ≤ 3 days postoperatively or until delirium resolves
postoperative delirium - severity
rated through CAM-S (Confusion Assessment Method - Severity) if patient was identified to be delirious
Time frame: ≤ 3 days postoperatively or until delirium resolves
postoperative cognitive dysfunction - severity
CERAD-Plus (Consortium to Establish a Registry for Alzheimer's Disease - Plus)
Time frame: baseline and 3 months postoperatively
pre- and postoperative intelligence
MWT-B (Mehrfachwahl-Wortschatz-Intelligenztest - B)
Time frame: baseline and 3 months postoperatively
Markers of systemic inflammation
C-reactive protein, Interleukins, Tumor necrosis factor among others
Time frame: ≤ 2 days postoperatively
Markers of neuroinflammation
Glial fibrillary acidic protein among others
Time frame: ≤ 2 days postoperatively
Markers of oxidative and metabolic stress
Malondialdehyd
Time frame: ≤ 2 days postoperatively
Patient Reported Quality of life
PROMIS-29 (Patient-Reported Outcomes Measurement Information System- Profile 29 incl. proxy-rating)
Time frame: baseline and 3 months postoperatively
Patient Reported Quality of life - 2
SF-36 (Short Form 36)
Time frame: baseline and 3 months postoperatively
Anxiety and depression
HADS (Hospital Anxiety and Depression Scale)
Time frame: baseline and 3 months postoperatively
Frailty
Groningen Frailty Scale
Time frame: baseline and 3 months postoperatively
Structural magnetic resonance imaging
White matter lesions
Time frame: baseline and 3 months postoperatively
Functional magnetic resonance imaging
Resting state networks
Time frame: baseline and 3 months postoperatively
Cerebral vasculature
Ultrasound of extra- and intracranial cerebral arteries
Time frame: baseline
Genetic polymorphisms
Time frame: baseline
This study is terminated, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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University Medicine Greifswald