- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01881646
Postoperative Neuroinflammation and Cognitive Dysfunction After Abdominal Surgery (POPE)
January 10, 2017 updated by: Lars I Eriksson, Karolinska University Hospital
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
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
8
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Positron emission tomography (PET)
Positron emission tomography (PET) using [11C]PBR28
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Preoperatively, once at postoperative day 2-5 and after 3 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive testing
Time Frame: Preoperatively and after 3 month
|
Postoperative cognitive test battery according to the ISPOCD protocol, see Moller JT et al, Lancet 1998.
|
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
|
Inflammatory biomarkers and genetic analysis of inflammatory biomarkers in blood.
|
Preoperatively, once at postoperative day 2-5 and after 3 month, i.e. at the same time as the PET investigation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Lars I Eriksson, MD,PhD, Professor, Karolinska University Hospital and Karolinska Institutet
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (ACTUAL)
February 1, 2016
Study Completion (ACTUAL)
February 1, 2016
Study Registration Dates
First Submitted
June 13, 2013
First Submitted That Met QC Criteria
June 17, 2013
First Posted (ESTIMATE)
June 19, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
January 11, 2017
Last Update Submitted That Met QC Criteria
January 10, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- POPE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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