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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02574234
Acronym
APOCOGNIT
Enrollment
88
Registered
2015-10-12
Start date
2016-03-30
Completion date
2018-03-12
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

Keywords

Postoperative cognitive disorders POCD, inflammation, Surgery

Brief summary

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.

Detailed 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…).

Interventions

OTHERDetermination of apelin and inflammatory cytokines

A blood sample will be conducted at baseline, on day 1 and day 7 post operative to meter inflammatory cytokines (IL1B, IL1-ra, IL6) and apelin.

Evaluation of preoperative cognitive performance by achieving a IQCODE, an MMS and an IADL scale.

OTHERLiquid sampling cerebrospinal

Determination of the concentrations of inflammatory cytokines and apelin in cerebrospinal fluid perioperatively.

OTHERPostoperative delirium research

Using the scale Confusion Assessment Method (CAM) for screening and delirium diagnosis. This research will be daily lasted, during the first 7 days postoperative.

OTHERResidual cognitive dysfunction research

Evaluation of postoperative cognitive performance by achieving a IQCODE, an MMS and an IADL scale realised on day 1 and day 7 postoperative. Realization of the IQCODE and IADL three months after the operation in a telephone interview.

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative delirium occurrence.day1 to day 7 post-operationEvaluation of the occurrence of postoperative delirium evaluated by the Confusion Assessment Method (CAM)

Secondary

MeasureTime frameDescription
Evaluation of postoperative cognitive functions.day 1 to day 7 and 3 month after post-operationEvaluation with IQCODE questionary (Informant Questionary on Cognitive Decline in the Elderly)
Assessment of the autonomy.day 1 to day 7 and 3 month after post-operationEvaluation with IADL scale (Instrumental Activities Scale of Everyday Life)
Plasma concentration of apelin.day 1 to day 7 post operation
Plasma concentration of inflammatory cytokines.24 hours before operation, day 1 to day 7 post operation
Concentration of inflammatory cytokines and apelin in the cerebrospinal fluid.day 0 (operation day)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026