Neuroinflammation and Cognitive Dysfunction After Orthopedic Surgery

Surgery Clinical Trial

Official title:

Neuroinflammation and Cognitive Dysfunction After Orthopedic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02759965
• Other study ID #: NEUPORT
• Status: Completed
• Start date: September 1, 2014
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2019
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 31, 2018
• Est. primary completion date: March 30, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Phase Reaction
• Acute-Phase Reaction
• Cognitive Dysfunction
• Surgery

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg
Sweden	Department of Anesthesiology, Surgical Services and Intensive Care Medicine, Karolinska University Hospital, Solna	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuroinflammation measured as IL-6 in CSF	IL-6 in CSF	Up to 48 hours postoperatively
Secondary	Cognitive function	A cognitive test battery will be applied	Before surgery, within 7 days after surgery and 3 month after surgery
Secondary	Peripheral inflammatory response	Cytokines i peripheral blood	Up to 48 hours
Secondary	Neuroinflammation	CNS specific markers in blood	Up to 48 hours
Secondary	Neuroinflammation	CNS specific markers in CSF	Up to 48 hours postoperatively
Secondary	Neuroinflammation	INflammatory Inflammatory markers in CSF	Up to 48 hours postoperatively