Neuroinflammation and Cognitive Dysfunction After Orthopedic Surgery

Completed

• Conditions: Surgery; Acute Phase Reaction

• Registration Number: NCT02759965
• Lead Sponsor: Karolinska University Hospital

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.

Study Timeline

• Study Start: 2014-09-01
• Study First Submitted: 2014-11-10
• Primary Completion: 2016-03-30
• Study First Submitted QC: 2016-05-02
• Study First Posted: 2016-05-03
• Study Completion: 2018-12-31
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-11
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 34

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neuroinflammation measured as IL-6 in CSF	Up to 48 hours postoperatively	IL-6 in CSF

Secondary Outcome Measures

Name	Time	Method
Peripheral inflammatory response	Up to 48 hours	Cytokines i peripheral blood
Neuroinflammation	Up to 48 hours postoperatively	INflammatory Inflammatory markers in CSF
Cognitive function	Before surgery, within 7 days after surgery and 3 month after surgery	A cognitive test battery will be applied

Trial Locations

Locations (2)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden

Department of Anesthesiology, Surgical Services and Intensive Care Medicine, Karolinska University Hospital, Solna; 🇸🇪 Stockholm, Sweden