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Clinical Trials/NCT02759965
NCT02759965
Completed
Not Applicable

Neuroinflammation and Cognitive Dysfunction After Orthopedic Surgery

Karolinska University Hospital2 sites in 1 country34 target enrollmentSeptember 1, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surgery
Sponsor
Karolinska University Hospital
Enrollment
34
Locations
2
Primary Endpoint
Neuroinflammation measured as IL-6 in CSF
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The primary hypothesis that orthopaedic surgery induces a neuroinflammatory response within 48 hours after elective hip or knee surgery and that there is an association between exaggerated CNS inflammatory response or impaired inflammatory resolution and postoperative cognitive dysfunction within one week and at three months postoperatively.

Detailed Description

Patients at 50-85 years of age undergoing orthopedic surgery will be investigated in the perioperative period to detect signs of neuroinflammation using serial CSF and blood sampling for 48 hours in combination with cognitive testing preoperatively, at 3-7 days and after 3 months.

Registry
clinicaltrials.gov
Start Date
September 1, 2014
End Date
December 31, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
Male

Investigators

Sponsor
Karolinska University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Lars I Eriksson

Professor

Karolinska University Hospital

Eligibility Criteria

Inclusion Criteria

  • ASA Physical Health Class 1-4
  • Age 50-85 years
  • Fluent in Swedish language
  • Scheduled for primary hip replacement surgery due to arthrosis
  • MMSE (minimental state test score \>= 25.

Exclusion Criteria

  • Patient refusal to participate in the trial
  • Current autoimmune disease, including arthritis
  • Ongoing smoking, snuff or other nicotine compound treatment
  • Significant neurologic or psychiatric disorder (such as Alzheimer's disease, Parkinson's disease, Multiple sclerosis, schizophrenia, depression, diagnosis of dementia or cognitive impairment as defined by a preoperative MMSE score ≤ 24
  • History of stroke with neurological sequelae.
  • Current severe cardiac (NYHA\>IV) or renal (plasma creatinine\> 0.250 mmol/l) Coagulopathy making spinal anesthesia and intrathecal catheter placement impossible
  • Terminal phase of a chronic disease.
  • Patient on chronic steroidal therapy
  • Poorly controlled diabetes mellitus.
  • Presumed uncooperativeness or legal incapacity.

Outcomes

Primary Outcomes

Neuroinflammation measured as IL-6 in CSF

Time Frame: Up to 48 hours postoperatively

IL-6 in CSF

Secondary Outcomes

  • Peripheral inflammatory response(Up to 48 hours)
  • Neuroinflammation(Up to 48 hours postoperatively)
  • Cognitive function(Before surgery, within 7 days after surgery and 3 month after surgery)

Study Sites (2)

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