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Clinical Trials/NCT03486288
NCT03486288
Terminated
N/A

Kognitive Störungen Nach Elektiver Wirbelsäulenchirurgie Bei Älteren

University Medicine Greifswald1 site in 1 country124 target enrollmentFebruary 6, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cognitive Impairment
Sponsor
University Medicine Greifswald
Enrollment
124
Locations
1
Primary Endpoint
postoperative delirium - incidence
Status
Terminated
Last Updated
4 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 6, 2018
End Date
March 30, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Medicine Greifswald
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • age ≥ 60 years
  • scheduled for elective spine surgery without opening the dura
  • patient can give informed consent him-/herself
  • German native speaker

Exclusion Criteria

  • dementia or neurodegenerative disease
  • psychiatric disease
  • prescription of CNS-active medication (e.g. antidepressants, antipsychotics, sedatives, alpha-1-antagonists)
  • impossible to participate in follow-up
  • participation in an interventional trial
  • electronic or displacable metallic implants
  • active neoplasm

Outcomes

Primary Outcomes

postoperative delirium - incidence

Time Frame: ≤ 3 days postoperatively

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

Secondary Outcomes

  • pre- and postoperative intelligence(baseline and 3 months postoperatively)
  • postoperative delirium - duration(≤ 3 days postoperatively or until delirium resolves)
  • Patient Reported Quality of life(baseline and 3 months postoperatively)
  • postoperative delirium - severity(≤ 3 days postoperatively or until delirium resolves)
  • postoperative cognitive dysfunction - severity(baseline and 3 months postoperatively)
  • Markers of systemic inflammation(≤ 2 days postoperatively)
  • Patient Reported Quality of life - 2(baseline and 3 months postoperatively)
  • Markers of oxidative and metabolic stress(≤ 2 days postoperatively)
  • Structural magnetic resonance imaging(baseline and 3 months postoperatively)
  • Cerebral vasculature(baseline)
  • Markers of neuroinflammation(≤ 2 days postoperatively)
  • Anxiety and depression(baseline and 3 months postoperatively)
  • Frailty(baseline and 3 months postoperatively)
  • Functional magnetic resonance imaging(baseline and 3 months postoperatively)
  • Genetic polymorphisms(baseline)

Study Sites (1)

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