Neuroinflammation and Cognitive Dysfunction After Orthopedic Surgery

NCT ID: NCT02759965

Last Updated: 2019-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-01

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Surgery Acute Phase Reaction

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lars I Eriksson

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status

Department of Anesthesiology, Surgical Services and Intensive Care Medicine, Karolinska University Hospital, Solna

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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NEUPORT

Identifier Type: -

Identifier Source: org_study_id

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