Clinical trial NCT02759965: Neuroinflammation and Cognitive Dysfunction After Orthopedic Surgery
Official title: Neuroinflammation and Cognitive Dysfunction After Orthopedic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Acute Phase Reaction
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
First posted: 2016-05-03
Enrollment: 34
Sex: MALE
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 34 elective orthopedic patients undergoing hip or knee arthroplasty

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.

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.

Primary outcomes:
measure: Neuroinflammation measured as IL-6 in CSF
timeFrame: Up to 48 hours postoperatively
Secondary outcomes:
measure: Cognitive function
timeFrame: Before surgery, within 7 days after surgery and 3 month after surgery
measure: Peripheral inflammatory response
timeFrame: Up to 48 hours
measure: Neuroinflammation
timeFrame: Up to 48 hours
measure: Neuroinflammation
timeFrame: Up to 48 hours postoperatively
measure: Neuroinflammation
timeFrame: Up to 48 hours postoperatively
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Stockholm
country: Sweden
facility: Department of Anesthesiology, Surgical Services and Intensive Care Medicine, Karolinska University Hospital, Solna
Study officials:
References: