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NCT Number: NCT02574234

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

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.

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Key information

Conditions

Delirium Confusion Inflammation Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Toulouse, service d'orthopédie et traumatologie

Toulouse, France

About this study

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…).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Determination of apelin and inflammatory cytokines

Other

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.

Assessment of cognitive functions

Other

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

Liquid sampling cerebrospinal

Other

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

Postoperative delirium research

Other

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

Residual cognitive dysfunction research

Other

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.

Primary outcomes

  1. Postoperative delirium occurrence.

    Time frame: day1 to day 7 post-operation

    Evaluation of the occurrence of postoperative delirium evaluated by the Confusion Assessment Method (CAM)

Secondary outcomes

  1. Evaluation of postoperative cognitive functions.

    Time frame: day 1 to day 7 and 3 month after post-operation

    Evaluation with IQCODE questionary (Informant Questionary on Cognitive Decline in the Elderly)

  2. Assessment of the autonomy.

    Time frame: day 1 to day 7 and 3 month after post-operation

    Evaluation with IADL scale (Instrumental Activities Scale of Everyday Life)

  3. Plasma concentration of apelin.

    Time frame: day 1 to day 7 post operation

  4. Plasma concentration of inflammatory cytokines.

    Time frame: 24 hours before operation, day 1 to day 7 post operation

  5. Concentration of inflammatory cytokines and apelin in the cerebrospinal fluid.

    Time frame: day 0 (operation day)

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: APOCOGNIT

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 12, 2015
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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