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Influence of Apelin Levels on Postoperative Cognitive Disorders After Orthopedic Surgery in Elderlies (APOCOGNIT)

T

Toulouse University Hospital

Status

Completed

Conditions

Delirium

Treatments

Other: Determination of apelin and inflammatory cytokines
Other: Postoperative delirium research
Other: Assessment of cognitive functions
Other: Liquid sampling cerebrospinal
Other: Residual cognitive dysfunction research

Study type

Interventional

Funder types

Other

Identifiers

NCT02574234
RC31/14/7313

Details and patient eligibility

About

No successful strategy is proposed to patients submitted to important surgery to reduce the incidence of postoperative cognitive disorders (POCD) onset. This project propose to measure plasma levels of apelin in wide population submitted to orthopedic surgery. Apelin could be involved in anti-inflammatory processes. Apelin levels before and after surgery correlated to postoperative cognitive disorders symptom measured by PET-Scan could be an important predictive or diagnostic marker to adapt therapeutic strategy to fight against postoperative cognitive disorders.

Full description

It has been now clearly shown that important surgery with general anesthesia could be strongly associated to postoperative cognitive disorders few months after the intervention especially in elderlies. No strategy is really efficient to fight against this phenomenon that could lead to Alzheimer disease development. In order to prognosticate and characterize the potential risk to develop cognitive troubles after a surgery, this study propose to evaluate the potential predictive capacity of apelin in a cohort of young and old adult undergoing an orthopedic surgery. Apelin is a peptide involved in different physiological as well physiopathological pathways. This peptide, involved in osteogenesis and inflammatory processes, has also been described to be neuroprotective. Yet, hippocampic neuroinflammation has been related in case of postoperative cognitive disorders in human as well as in mice model of surgery. Taken together, these results seem to indicate that apelin could be a therapeutic target and be predictive of the postoperative cognitive disorders onset.

This study will measure plasma apelin levels in young and old adult one day before and after a programed orthopedic surgery. Moreover, to correlate apelin amounts with inflammation processes, protocol will quantify inflammatory cytokines in plasma (IL6, IL1, TNFα). These results will be compared to measures of brain b-amyloid deposit assessed by PET-Scan technology.

The follow-up of the patients will be done during 3 months in order to evaluate the postoperative cognitive disorders or the cognitive troubles associated to surgery (memory fail, decrease of cognitive reserve...).

Enrollment

88 patients

Sex

All

Ages

75+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients submitted to a programed orthopedic surgery
  • Patients with pre- and post-surgery check-up.

Exclusion criteria

  • Non programed orthopedic surgery (emergency)
  • Patients with sepsis
  • Patients submitted to orthopedic surgery but with ambulatory management.
  • Existence of justice backup, curators or supervision.
  • Absence of indication for a pre- or post-surgery check-up.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

88 participants in 1 patient group

Patients with orthopedic surgery
Experimental group
Description:
Patients will be included in the consultation of anesthesia. The usual laboratory tests will be carried out and a determination of apelin and inflammatory cytokines. Assessment of cognitive functions using the Informant Questionnaire on Cognitive Decline in the Elderly (ICQODE), Mini Mental State examination (MMS) and the scale of Instrumental activities of daily living (IADL). Day of surgery: liquid sampling cerebrospinal. Day 1 to day 7 postoperatively: determination of inflammatory cytokines and apelin, postoperative delirium research (Confusion Assessment Method (CAM)), residual cognitive dysfunction research (MMS, IADL, IQCODE). 3 months after operation: evaluation of cognitive performance (IQCODE, IADL)
Treatment:
Other: Determination of apelin and inflammatory cytokines
Other: Residual cognitive dysfunction research
Other: Assessment of cognitive functions
Other: Liquid sampling cerebrospinal
Other: Postoperative delirium research

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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