SurgeryNCT02759965
Neuroinflammation and Cognitive Dysfunction After Orthopedic Surgery
An observational study of Surgery and Acute Phase Reaction, run by Karolinska University Hospital at 2 sites in Sweden.
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… Read more about this study
- Who is it for?
- Ages 50 to 85 years, men only
- Conditions the study is for
- Surgery, Acute Phase Reaction
- How many people
- 34 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Sep 2014to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: 34 elective orthopedic patients undergoing hip or knee arthroplasty
Who may be able to join
- 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.
Who cannot join
- 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
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- Terminal phase of a chronic disease.
- Patient on chronic steroidal therapy
- Poorly controlled diabetes mellitus.
- Presumed uncooperativeness or legal incapacity.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Sahlgrenska University Hospital
Gothenburg
Department of Anesthesiology, Surgical Services and Intensive Care Medicine, Karolinska University Hospital, Solna
Stockholm, SE-17176
About this study
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.
Read the 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.
- Conditions
- Surgery, Acute Phase Reaction
- Medical subject headings
- Acute-Phase Reaction
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuroinflammation measured as IL-6 in CSF
IL-6 in CSF
Measured: Up to 48 hours postoperatively
Secondary outcomes (5)
Cognitive function
A cognitive test battery will be applied
Measured: Before surgery, within 7 days after surgery and 3 month after surgery
Peripheral inflammatory response
Cytokines i peripheral blood
Measured: Up to 48 hours
Neuroinflammation
CNS specific markers in blood
Measured: Up to 48 hours
Neuroinflammation
CNS specific markers in CSF
Measured: Up to 48 hours postoperatively
Neuroinflammation
INflammatory Inflammatory markers in CSF
Measured: Up to 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study start1 Sep 2014
- Primary completion30 Mar 2016
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital
- Responsible party
- Principal investigator, Lars I Eriksson, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02759965
- Sponsor's protocol ID
- NEUPORT
- Status last verified
- Apr 2019
- First submitted
- 10 Nov 2014
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroinflammation and Cognitive Dysfunction After Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT02759965
- Acronym / sponsor ID
- NEUPORT
- Conditions
- Surgery, Acute Phase Reaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 30 Mar 2016 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 3 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 34 elective orthopedic patients undergoing hip or knee arthroplasty
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neuroinflammation measured as IL-6 in CSF
Time frame: Up to 48 hours postoperatively
IL-6 in CSF
5 secondary outcomes
Cognitive function
Time frame: Before surgery, within 7 days after surgery and 3 month after surgery
Peripheral inflammatory response
Time frame: Up to 48 hours
Neuroinflammation
Time frame: Up to 48 hours
Neuroinflammation
Time frame: Up to 48 hours postoperatively
Neuroinflammation
Time frame: Up to 48 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Acute Phase Reaction, run by Karolinska University Hospital at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuroinflammation measured as IL-6 in CSF (time frame: Up to 48 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.