Neuroinflammation and Cognitive Dysfunction After Orthopedic Surgery

April 11, 2019 updated by: Lars I Eriksson, Karolinska University Hospital
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden
        • Sahlgrenska University Hospital
      • Stockholm, Sweden, SE-17176
        • Department of Anesthesiology, Surgical Services and Intensive Care Medicine, Karolinska University Hospital, Solna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

34 elective orthopedic patients undergoing hip or knee arthroplasty

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuroinflammation measured as IL-6 in CSF
Time Frame: Up to 48 hours postoperatively
IL-6 in CSF
Up to 48 hours postoperatively

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Collaborators

Sahlgrenska University Hospital, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

March 30, 2016

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

November 10, 2014

First Submitted That Met QC Criteria

May 2, 2016

First Posted (Estimate)

May 3, 2016

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 11, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEUPORT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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