NeuroinflammationNCT03058328
The White Blood Cell Reactivity Following Surgical Trauma and Associated Regulatory Mechanisms.
An observational study of Neuroinflammation, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
The purpose of this study is to describe numerical and functional changes in the white blood cell efter surgical trauma. Further, observed immune cell changes correlate to heart rate variability and cognitive function will be assessed. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Neuroinflammation
- What is being tested?
- Cognitive testing, testing of heart rate variability and blood samples
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 31 Jan 2017to 31 Dec 2023
- 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 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diagnosed prostate disease who are scheduled for elective robot assisted prostate surgery (RALP) and who are otherwise healthy, with a BMI below 33 and who score >23 performance points on Mini-mental state examination (MMSE).
Who may be able to join
- Diagnosed prostate disease who are scheduled for elective robot assisted prostate surgery (RALP) and who are otherwise healthy
- A body mass index (BMI) below 33
- Mini-mental state examination (MMSE) scoring >23
Who cannot join
- Neurodegenerative disease
- Significant psychiatric illness
- Previous stroke
- Pacemaker, myocardial infarction or cardiac arrhythmias,
- Known obstructive coronary artery disease, left ventricular hypertrophy or New York Heart Association (NYHA) class 2-4 heart failure
- Chronic pain or inflammatory disease such as rheumatoid arthritis, inflammatory bowel disease, SLE, psoriasis
Show all 17Show fewer
- Steroidal therapy
- Statin medication
- Medication with ß-blockers, anti-cholinergic medication
- Poorly controlled diabetes mellitus or any other condition known to cause autonomic dysfunction
- Abuse of alcohol or drugs
- Previous splenectomy
- Presumed uncooperativeness or legal incapacity.
- The patient should not have:
- undergone surgery the last 6 months
- been treated for cancer the last 12 months
- been treated for infectious disease the previous month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-surgery Systemic Inflammation and Neuro-immune Interactions
The purpose of this study is to describe numerical and functional changes in the white blood cell efter surgical trauma. Further, observed immune cell changes correlate to heart rate variability and cognitive function will be assessed.
Read the detailed description
Surgical trauma causes release of damage-associated molecular patterns (DAMPs) and other alarmines (e.g. HMGB-1) targeting receptors on local cells of the innate immune system, such as macrophages. This cellular response to trauma is followed by a rapid release of an array of inflammatory mediators (e.g. TNFα, IL-1B, IL-6, IL-8, IL-10) being dependent on intracellular activation of nuclear factor NF-kB. Until recently it was believed that the brain is protected from this cascade of inflammatory mediators primarily due to an intact blood-brain-barrier (BBB). However, there is now a growing body of evidence that long term impairment of brain functions is associated with trauma-induced activation of the brain innate immune system with subsequent impairment of higher cognitive processes and risk for later permanent dementia. Yet, the link between systemic inflammation and cognitive impairment is not fully understood.
Recent studies have mapped periphery-to-brain-signaling after surgical trauma and the impact of major surgical trauma on the human brain by serial PET-imaging. In series of surgical patients, profound and biphasic changes in brain immune activity after surgery has been demonstrated after major abdominal surgery with signs of early depression followed by an increased immune activity at 3 months postoperatively. These biphasic changes in brain immunity seem to be aligned with simultaneous changes in whole blood immune reactivity to LPS suggesting a close link between brain and peripheral immune systems in regulation of acute inflammation and immune responses. Preclinical work in surgical animal models indicates disruption of the BBB with migration of peripheral macrophages into the brain as a pathway of potential importance. Evidence from an orthopedic surgery model in mice of trauma-induced altered hippocampal neuro-immune activity further raises the question whether peripheral markers of neurodegeneration (S100b, neurofilament light NFL, ptau, beta-amyloid) are associated with POCD.
The immune-regulatory role of the brain via the cholinergic anti-inflammatory reflex pathway (mediated by the vagal nerve) has been identified as potential target for immune-modulatory treatment strategies in systemic inflammation. We have moreover demonstrated a distinct release of human carotid body inflammatory mediators at hypoxia and gene expression related to inflammatory mediators, suggesting a potential role of the human carotid body in periphery-to-brain immune-signaling. Modulation of a vagal nerve-derived inflammatory reflex pathway by electrical stimulation has recently been successfully applied in treatment of chronic inflammation among patients with rheumatoid arthritis.
The hypothesis is that vagal nerve activity modulates systemic inflammation in patients after major surgery and that this modulation is associated with cognitive performance in the postoperative period.
With a more comprehensive understanding of immune-to-brain signaling after surgical trauma and how this biphasic inflammatory response pattern is regulated by cellular and neuronal components, the impact of immune modulation on key processes behind surgery-induced brain dysfunction can be explored, and possible neural and humoral targets for relevant anti-inflammatory treatments established.
In abdominal surgery patients we will map inflammatory periphery-to-brain communication by description of the temporal association between brain regulation of peripheral immunity (i.e., temporal changes in vagal nerve activity as measured by serial measurements of heart rate variability), repeated blood reactivity to LPS by serial ex vivo LPS challenge and simultaneous plasma/serum-borne CNS inflammatory and brain injury biomarkers to explore the impact of changes in systemic and brain immune function after surgery on long-term cognitive performance.
- Conditions
- Neuroinflammation
- Being tested
- Cognitive testing, testing of heart rate variability and blood samples
- Keywords
- Inflammation/physiopathology, Immune System/immunology,, Neuroimmunomodulation/physiology, General Surgery, Heart Rate/physiology*Vagus Nerve/physiology*
- Medical subject headings
- Neuroinflammatory Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive testing, testing of heart rate variability and blood samplesOther
No intervention. Registration of ECG, cognitive testing and blood sampling is performed in the perioperative period and during follow up.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in subsets of Monocytes after surgical trauma
Changes in subsets of Monocytes after surgical trauma
Measured: Up to 6 months after surgery
Secondary outcomes (4)
T-cell numbers after surgical trauma.
T-cell numbers after surgical trauma.
Measured: Up to 6 months after surgery
B-cell numbers after surgical trauma.
B-cell numbers after surgical trauma.
Measured: Up to 6 months after surgery
T-cell functionality changes after surgical trauma.
T-cell functionality changes after surgical trauma.
Measured: Up to 6 months after surgery
B-cell functionality changes after surgical trauma.
B-cell functionality changes after surgical trauma.
Measured: Up to 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start31 Jan 2017
- Primary completion31 Dec 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroinflammationStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Lars I Eriksson, Karolinska University Hospital
- Investigators
- Lars I Eriksson, Principal investigator, Karolinska University Hospital and Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058328
- Sponsor's protocol ID
- POSINI2
- Status last verified
- Jan 2024
- First submitted
- 13 Jan 2017
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-surgery Systemic Inflammation and Neuro-immune Interactions
- ClinicalTrials.gov ID
- NCT03058328
- Acronym / sponsor ID
- POSINI2
- Conditions
- Neuroinflammation
- Keywords
- Inflammation/physiopathology, Immune System/immunology,, Neuroimmunomodulation/physiology, General Surgery, Heart Rate/physiology*Vagus Nerve/physiology*
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- 31 Jan 2017 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 20 Feb 2017 (actual)
- 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 purpose of this study is to describe numerical and functional changes in the white blood cell efter surgical trauma. Further, observed immune cell changes correlate to heart rate variability and cognitive function will be assessed.
Detailed description
Surgical trauma causes release of damage-associated molecular patterns (DAMPs) and other alarmines (e.g. HMGB-1) targeting receptors on local cells of the innate immune system, such as macrophages. This cellular response to trauma is followed by a rapid release of an array of inflammatory mediators (e.g. TNFα, IL-1B, IL-6, IL-8, IL-10) being dependent on intracellular activation of nuclear factor NF-kB. Until recently it was believed that the brain is protected from this cascade of inflammatory mediators primarily due to an intact blood-brain-barrier (BBB). However, there is now a growing body of evidence that long term impairment of brain functions is associated with trauma-induced activation of the brain innate immune system with subsequent impairment of higher cognitive processes and risk for later permanent dementia. Yet, the link between systemic inflammation and cognitive impairment is not fully understood.
Recent studies have mapped periphery-to-brain-signaling after surgical trauma and the impact of major surgical trauma on the human brain by serial PET-imaging. In series of surgical patients, profound and biphasic changes in brain immune activity after surgery has been demonstrated after major abdominal surgery with signs of early depression followed by an increased immune activity at 3 months postoperatively. These biphasic changes in brain immunity seem to be aligned with simultaneous changes in whole blood immune reactivity to LPS suggesting a close link between brain and peripheral immune systems in regulation of acute inflammation and immune responses. Preclinical work in surgical animal models indicates disruption of the BBB with migration of peripheral macrophages into the brain as a pathway of potential importance. Evidence from an orthopedic surgery model in mice of trauma-induced altered hippocampal neuro-immune activity further raises the question whether peripheral markers of neurodegeneration (S100b, neurofilament light NFL, ptau, beta-amyloid) are associated with POCD.
The immune-regulatory role of the brain via the cholinergic anti-inflammatory reflex pathway (mediated by the vagal nerve) has been identified as potential target for immune-modulatory treatment strategies in systemic inflammation. We have moreover demonstrated a distinct release of human carotid body inflammatory mediators at hypoxia and gene expression related to inflammatory mediators, suggesting a potential role of the human carotid body in periphery-to-brain immune-signaling. Modulation of a vagal nerve-derived inflammatory reflex pathway by electrical stimulation has recently been successfully applied in treatment of chronic inflammation among patients with rheumatoid arthritis.
The hypothesis is that vagal nerve activity modulates systemic inflammation in patients after major surgery and that this modulation is associated with cognitive performance in the postoperative period.
With a more comprehensive understanding of immune-to-brain signaling after surgical trauma and how this biphasic inflammatory response pattern is regulated by cellular and neuronal components, the impact of immune modulation on key processes behind surgery-induced brain dysfunction can be explored, and possible neural and humoral targets for relevant anti-inflammatory treatments established.
In abdominal surgery patients we will map inflammatory periphery-to-brain communication by description of the temporal association between brain regulation of peripheral immunity (i.e., temporal changes in vagal nerve activity as measured by serial measurements of heart rate variability), repeated blood reactivity to LPS by serial ex vivo LPS challenge and simultaneous plasma/serum-borne CNS inflammatory and brain injury biomarkers to explore the impact of changes in systemic and brain immune function after surgery on long-term cognitive performance.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosed prostate disease who are scheduled for elective robot assisted prostate surgery (RALP) and who are otherwise healthy, with a BMI below 33 and who score >23 performance points on Mini-mental state examination (MMSE).
Key inclusion criteria (3 listed)
- Diagnosed prostate disease who are scheduled for elective robot assisted prostate surgery (RALP) and who are otherwise healthy
- A body mass index (BMI) below 33
- Mini-mental state examination (MMSE) scoring >23
Key exclusion criteria (17 listed)
- Neurodegenerative disease
- Significant psychiatric illness
- Previous stroke
- Pacemaker, myocardial infarction or cardiac arrhythmias,
- Known obstructive coronary artery disease, left ventricular hypertrophy or New York Heart Association (NYHA) class 2-4 heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive testing, testing of heart rate variability and blood samplesNo intervention. Registration of ECG, cognitive testing and blood sampling is performed in the perioperative period and during follow up. | Other | – |
Primary outcome
Changes in subsets of Monocytes after surgical trauma
Time frame: Up to 6 months after surgery
Changes in subsets of Monocytes after surgical trauma
4 secondary outcomes
T-cell numbers after surgical trauma.
Time frame: Up to 6 months after surgery
B-cell numbers after surgical trauma.
Time frame: Up to 6 months after surgery
T-cell functionality changes after surgical trauma.
Time frame: Up to 6 months after surgery
B-cell functionality changes after surgical trauma.
Time frame: Up to 6 months after surgery
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 17 Jan 2024.
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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.
Lars I Eriksson principal investigator
Karolinska University Hospital and Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroinflammation, run by Karolinska University Hospital at 1 site 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 3 inclusion and 17 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 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Changes in subsets of Monocytes after surgical trauma (time frame: Up to 6 months after surgery). 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 17 Jan 2024.