Cognitive Impairment Following Elective Spine Surgery

Cognitive Impairment Clinical Trial

— CONFESS  

Official title:

Kognitive Störungen Nach Elektiver Wirbelsäulenchirurgie Bei Älteren

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03486288
• Other study ID #: BB 192/17
• Status: Terminated
• Start date: February 6, 2018
• Est. completion date: March 30, 2021

Study information

• Verified date: May 2021
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 124
• Est. completion date: March 30, 2021
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Delirium
• Postoperative Delirium
• Spine Fusion

Locations

Country	Name	City	State
Germany	Department of Neurology	Greifswald	Mecklenburg-Vorpommern

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	= 3 days postoperatively
Secondary	postoperative delirium - duration	screening through Nu-DESC = 2 and verification of screening procedure by DSM-V criteria DSM-V once during each shift	= 3 days postoperatively or until delirium resolves
Secondary	postoperative delirium - severity	rated through CAM-S (Confusion Assessment Method - Severity) if patient was identified to be delirious	= 3 days postoperatively or until delirium resolves
Secondary	postoperative cognitive dysfunction - severity	CERAD-Plus (Consortium to Establish a Registry for Alzheimer's Disease - Plus)	baseline and 3 months postoperatively
Secondary	pre- and postoperative intelligence	MWT-B (Mehrfachwahl-Wortschatz-Intelligenztest - B)	baseline and 3 months postoperatively
Secondary	Markers of systemic inflammation	C-reactive protein, Interleukins, Tumor necrosis factor among others	= 2 days postoperatively
Secondary	Markers of neuroinflammation	Glial fibrillary acidic protein among others	= 2 days postoperatively
Secondary	Markers of oxidative and metabolic stress	Malondialdehyd	= 2 days postoperatively
Secondary	Patient Reported Quality of life	PROMIS-29 (Patient-Reported Outcomes Measurement Information System- Profile 29 incl. proxy-rating)	baseline and 3 months postoperatively
Secondary	Patient Reported Quality of life - 2	SF-36 (Short Form 36)	baseline and 3 months postoperatively
Secondary	Anxiety and depression	HADS (Hospital Anxiety and Depression Scale)	baseline and 3 months postoperatively
Secondary	Frailty	Groningen Frailty Scale	baseline and 3 months postoperatively
Secondary	Structural magnetic resonance imaging	White matter lesions	baseline and 3 months postoperatively
Secondary	Functional magnetic resonance imaging	Resting state networks	baseline and 3 months postoperatively
Secondary	Cerebral vasculature	Ultrasound of extra- and intracranial cerebral arteries	baseline
Secondary	Genetic polymorphisms		baseline