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Neuroinflammation and Cognitive Dysfunction After Orthopedic Surgery

Sponsor
Karolinska University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02759965
Collaborator
Sahlgrenska University Hospital, Sweden (Other)
34
Enrollment
2
Locations
52
Actual Duration (Months)
17
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    34 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Neuroinflammation and Cognitive Dysfunction After Orthopedic Surgery
    Actual Study Start Date :
    Sep 1, 2014
    Actual Primary Completion Date :
    Mar 30, 2016
    Actual Study Completion Date :
    Dec 31, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Neuroinflammation measured as IL-6 in CSF [Up to 48 hours postoperatively]

      IL-6 in CSF

    Secondary Outcome Measures

    1. Cognitive function [Before surgery, within 7 days after surgery and 3 month after surgery]

      A cognitive test battery will be applied

    2. Peripheral inflammatory response [Up to 48 hours]

      Cytokines i peripheral blood

    3. Neuroinflammation [Up to 48 hours]

      CNS specific markers in blood

    4. Neuroinflammation [Up to 48 hours postoperatively]

      CNS specific markers in CSF

    5. Neuroinflammation [Up to 48 hours postoperatively]

      INflammatory Inflammatory markers in CSF

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 85 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sahlgrenska University Hospital Gothenburg Sweden
    2 Department of Anesthesiology, Surgical Services and Intensive Care Medicine, Karolinska University Hospital, Solna Stockholm Sweden SE-17176

    Sponsors and Collaborators

    • Karolinska University Hospital
    • Sahlgrenska University Hospital, Sweden

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lars I Eriksson, Professor, Karolinska University Hospital
    ClinicalTrials.gov Identifier:
    NCT02759965
    Other Study ID Numbers:
    • NEUPORT
    First Posted:
    May 3, 2016
    Last Update Posted:
    Apr 16, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Acute-Phase Reaction
    Cognitive Dysfunction

    Study Results

    No Results Posted as of Apr 16, 2019