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Postoperative Neuroinflammation and Cognitive Dysfunction After Abdominal Surgery (POPE)

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ClinicalTrials.gov Identifier: NCT01881646
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : January 11, 2017
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Lars I Eriksson, Karolinska University Hospital

Brief 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

Condition or disease Intervention/treatment Phase
Anesthesia Surgery Neurogenic Inflammation Cognitive Disorders Radiation: Positron emission tomography (PET) using [11C]PBR28 Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : June 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Arm Intervention/treatment
Experimental: Positron emission tomography (PET)
Positron emission tomography (PET) using [11C]PBR28
Radiation: Positron emission tomography (PET) using [11C]PBR28



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients 60-75 years of age. American Society for Anesthesiologist' criteria (ASA) physical status I-III
  2. Lower abdominal surgery (hysterectomy/prostatectomy) under general anaesthesia
  3. Obtained consent within 3 months before execution of the study.

Exclusion Criteria:

  1. Patient's refusal to participate in the trial
  2. Ongoing smoking, snuff or other nicotine compound treatment
  3. 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.
  4. History of stroke with neurological sequelae
  5. Surgical procedure scheduled for regional anaesthesia.
  6. Severe cardia and/or renal and/or hepatic impairment.
  7. Coagulopathy.
  8. Terminal phase of a chronic disease.
  9. Patient on steroidal or non-steroidal anti-inflammatory drugs.
  10. Admission B-Glucose > 15 mmol/litre or poorly controlled diabetes mellitus.
  11. Presumed uncooperativeness or legal incapacity.
  12. Preoperative or later postoperative B-hemoglobin < 90 g/L.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881646


Sponsors and Collaborators
Karolinska University Hospital
University of Copenhagen
Investigators
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Principal Investigator: Lars I Eriksson, MD,PhD, Professor Karolinska University Hospital and Karolinska Institutet

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Responsible Party: Lars I Eriksson, Professor, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01881646     History of Changes
Other Study ID Numbers: POPE
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017
Keywords provided by Lars I Eriksson, Karolinska University Hospital:
Neuroinflammation
Postoperative cognitive dysfunction
Additional relevant MeSH terms:
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Neurogenic Inflammation
Inflammation
Cognitive Dysfunction
Cognition Disorders
Pathologic Processes
Neurocognitive Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases