AnesthesiaPhase 4POPENCT01881646
Postoperative Neuroinflammation and Cognitive Dysfunction After Abdominal Surgery
A Phase 4 study testing Positron emission tomography (PET) using [11C]PBR28 in people with Anesthesia and Surgery, run by Karolinska University Hospital.
Trial summary
The main purpose of this study is to assess the induction of neuroinflammation in brain regions of interest for learning and memory in adult patients undergoing urological surgery under general anesthesia Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Anesthesia, Surgery, Neurogenic Inflammation
- What is being tested?
- Positron emission tomography (PET) using [11C]PBR28
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Feb 2016
- Phase
- Phase 4
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 60-75 years of age. American Society for Anesthesiologist' criteria (ASA) physical status I-III
- Lower abdominal surgery (hysterectomy/prostatectomy) under general anaesthesia
- Obtained consent within 3 months before execution of the study.
Who cannot join
- Patient's refusal to participate in the trial
- Ongoing smoking, snuff or other nicotine compound treatment
- Disabling neuropsychiatrical disorder (a Mini mental State Examination (MMSE) score ≤ 24, diagnosis of dementia, Mb Alzheimer, Mb Parkinson, schizophrenia, or mental depression) or other signs of significant cognitive decline.
- History of stroke with neurological sequelae
- Surgical procedure scheduled for regional anaesthesia.
- Severe cardia and/or renal and/or hepatic impairment.
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- Coagulopathy.
- Terminal phase of a chronic disease.
- Patient on steroidal or non-steroidal anti-inflammatory drugs.
- Admission B-Glucose > 15 mmol/litre or poorly controlled diabetes mellitus.
- Presumed uncooperativeness or legal incapacity.
- Preoperative or later postoperative B-hemoglobin < 90 g/L.
About this study
The main purpose of this study is to assess the induction of neuroinflammation in brain regions of interest for learning and memory in adult patients undergoing urological surgery under general anesthesia
Read the detailed description
The investigators aim to study immune cell activation as a biomarker for neuroinflammation using the cell specific [11C]PBR28 probe as detected by PET imaging techniques.
- Conditions
- Anesthesia, Surgery, Neurogenic Inflammation, Cognitive Disorders
- Being tested
- Positron emission tomography (PET) using [11C]PBR28
- Keywords
- Neuroinflammation, Postoperative cognitive dysfunction
- Medical subject headings
- Neurogenic Inflammation, Cognitive Dysfunction, Neuroinflammatory Diseases, Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positron emission tomography (PET) using [11C]PBR28Radiation
| Study group | Role | What they receive |
|---|---|---|
| Positron emission tomography (PET) | Experimental | Positron emission tomography (PET) using [11C]PBR28 Receives: Radiation: Positron emission tomography (PET) using [11C]PBR28 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binding of the PET probe [11C]PBR28
PET imaging of brain regions of relevance for memory and learning will be compared between the pre- and postoperative states.
Measured: Preoperatively, once at postoperative day 2-5 and after 3 month
Secondary outcomes (2)
Cognitive testing
Postoperative cognitive test battery according to the ISPOCD protocol, see Moller JT et al, Lancet 1998.
Measured: Preoperatively and after 3 month
Inflammatory biomarkers
Inflammatory biomarkers and genetic analysis of inflammatory biomarkers in blood.
Measured: Preoperatively, once at postoperative day 2-5 and after 3 month, i.e. at the same time as the PET investigation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Lars I Eriksson, Karolinska University Hospital
- Investigators
- Lars I Eriksson, MD,PhD, Professor, Principal investigator, Karolinska University Hospital and Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881646
- Sponsor's protocol ID
- POPE
- Acronym
- POPE
- Status last verified
- Jan 2017
- First submitted
- 13 Jun 2013
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Neuroinflammation and Cognitive Dysfunction After Abdominal Surgery
- ClinicalTrials.gov ID
- NCT01881646
- Acronym / sponsor ID
- POPE / POPE
- Conditions
- Anesthesia, Surgery, Neurogenic Inflammation, Cognitive Disorders
- Keywords
- Neuroinflammation, Postoperative cognitive dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Jun 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 19 Jun 2013 (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 main purpose of this study is to assess the induction of neuroinflammation in brain regions of interest for learning and memory in adult patients undergoing urological surgery under general anesthesia
Detailed description
The investigators aim to study immune cell activation as a biomarker for neuroinflammation using the cell specific [11C]PBR28 probe as detected by PET imaging techniques.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Positron emission tomography (PET) | Experimental | Radiation: Positron emission tomography (PET) using [11C]PBR28Positron emission tomography (PET) using [11C]PBR28 |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients 60-75 years of age. American Society for Anesthesiologist' criteria (ASA) physical status I-III
- Lower abdominal surgery (hysterectomy/prostatectomy) under general anaesthesia
- Obtained consent within 3 months before execution of the study.
Key exclusion criteria (12 listed)
- Patient's refusal to participate in the trial
- Ongoing smoking, snuff or other nicotine compound treatment
- Disabling neuropsychiatrical disorder (a Mini mental State Examination (MMSE) score ≤ 24, diagnosis of dementia, Mb Alzheimer, Mb Parkinson, schizophrenia, or mental depression) or other signs of significant cognitive decline.
- History of stroke with neurological sequelae
- Surgical procedure scheduled for regional anaesthesia.
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 |
|---|---|---|
| Positron emission tomography (PET) using [11C]PBR28 | Radiation | Positron emission tomography (PET) |
Primary outcome
Binding of the PET probe [11C]PBR28
Time frame: Preoperatively, once at postoperative day 2-5 and after 3 month
PET imaging of brain regions of relevance for memory and learning will be compared between the pre- and postoperative states.
2 secondary outcomes
Cognitive testing
Time frame: Preoperatively and after 3 month
Inflammatory biomarkers
Time frame: Preoperatively, once at postoperative day 2-5 and after 3 month, i.e. at the same time as the PET investigation
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 11 Jan 2017.
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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, MD,PhD, Professor principal investigator
Karolinska University Hospital and Karolinska Institutet
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Positron emission tomography (PET) using [11C]PBR28 in people with Anesthesia and Surgery, run by Karolinska University Hospital.
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 12 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 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Binding of the PET probe [11C]PBR28 (time frame: Preoperatively, once at postoperative day 2-5 and after 3 month). 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 11 Jan 2017.