Clinical Trial: Neuroinflammation and Cognitive Dysfunction After Orthopedic Surgery
Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational
Official Title: Neuroinflammation and Cognitive Dysfunction After Orthopedic Surgery
Brief Summary: The primary hypothesis that orthopaedic surgery induces a neuroinflammatory response within 48 hours after elective hip 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 Summary: 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.
Sponsor: Karolinska University Hospital
Current Primary Outcome: Neuroinflammation measured as IL-6 in CSF [ Time Frame: Up to 48 hours postoperatively ]
Original Primary Outcome: Neuroinflammation [ Time Frame: Up to 48 hours postoperatively ]
Current Secondary Outcome:
- Cognitive function [ Time Frame: Before surgery, within 7 days after surgery and 3 month after surgery ]A cognitive test battery will be applied
- Peripheral inflammatory response [ Time Frame: Up to 48 hours ]Cytokines i peripheral blood
- Neuroinflammation [ Time Frame: Up to 48 hours ]CNS specific markers in blood
- Neuroinflammation [ Time Frame: Up to 48 hours postoperatively ]CNS specific markers in CSF
- Neuroinflammation [ Time Frame: Up to 48 hours postoperatively ]INflammatory Inflammatory markers in CSF
Original Secondary Outcome: Cognitive function [ Time Frame: Before surgery, within 7 days after surgery and 3 month after surgery ]
Information By: Karolinska University Hospital
Dates:
Date Received: November 10, 2014
Date Started: November 2014
Date Completion: June 2018
Last Updated: January 10, 2017
Last Verified: January 2017