Clinical trial NCT04907565: Impact of Obesity on Post-operative Cognitive Dysfunction: Role of Adipose Tissue
Official title: Impact of Obesity on Post-operative Cognitive Dysfunction: Role of Adipose Tissue
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Cognitive Impairment
Post-Operative Confusion
Keywords: Obesity
Post-operative cognitive dysfunction
Inflammation
Inflammatory cytokines
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2021-05-28
Enrollment: 408
Sex: ALL
Minimum age (years): 60
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: prospective, monocentric study conduct in Toulouse university hospital

Brief summary: This research aims at describing the relationship between white adipose tissue inflammation and post-operative cognitive dysfunctions.The possible link between inflammatory cytokines secretions of the white adipose tissue of a surgical wound and the arising of patient's cognitive dysfunction in the post-operative course will be investigated. The hypothesis is that obese patient's inflammation of the white adipose tissue leads to cognitive dysfunction.

Detailed description: The postoperative cognitive dysfunctions (POCD) are characterized by delirium and cognitive impairment. The delirium is defined by an acute altered attention with a fluctuating course. The post-operative cognitive impairment involves the early alteration of different functions including memory, attention and cognitive flexibility. POCD have a major impact in patient's morbidity. They are linked to the systemic inflammation induced by the surgical wound. The systemic inflammation leads to the rupture of the brain-blood barrier and to hippocampal inflammation. As hippocampus mediates the principal cognitive functions, hippocampal inflammation leads to POCD. Orthopedic and cardiac surgery are particularly concerned. Obesity is growing condition in the French population. It is linked to chronic systemic inflammation and altered cognitive functions. We think that obese people may present a susceptibility to POCD because of the pre-operative systemic inflammation.

Eligibility criteria: Inclusion Criteria:

* patient about to receive a hip arthroplasty under general anesthesia, elective cardiac surgery with cardiopulmonary bypass,
* patient with a MMSE score \> or = 20(/30),
* patient able to give informed consent

Exclusion Criteria:

* emergency surgery, or surgery in a septic context,
* patient with a known dementia or altered MMSE score (under 20)

Primary outcomes:
measure: Arising of POCD measured by a composite criterion
timeFrame: day 5 after surgery
Secondary outcomes:
measure: Variation of inflammatory cytokine levels from patient's plasma and patient's white adipose tissue (extract from a controlled medium).
timeFrame: Day 0 and day 5 after surgery
measure: Identification of a linked between inflammatory cytokine levels and the appearance of POCD.
timeFrame: day 5 after surgery
measure: Peri-operative variations of the protein S100B, an autonomy scale (IADL) and a quality of life scale (EQ5D).
timeFrame: day 5 after surgery
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Purpan University Hospital
Study officials:
affiliation: University Hospital, Toulouse
name: François Labaste, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: