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

February 23, 2024 updated by: University Hospital, Toulouse

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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…).

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France
        • CHU Toulouse, service d'orthopédie et traumatologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with orthopedic surgery

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)
Other: Determination 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.
Other: Assessment of cognitive functions
Evaluation of preoperative cognitive performance by achieving a IQCODE, an MMS and an IADL scale.
Other: Liquid sampling cerebrospinal
Determination of the concentrations of inflammatory cytokines and apelin in cerebrospinal fluid perioperatively.
Other: Postoperative 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.
Other: Residual 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
day1 to day 7 post-operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
day 1 to day 7 and 3 month after post-operation
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)
day 1 to day 7 and 3 month after post-operation
Plasma concentration of apelin.
Time Frame: day 1 to day 7 post operation
day 1 to day 7 post operation
Plasma concentration of inflammatory cytokines.
Time Frame: 24 hours before operation, day 1 to day 7 post operation
24 hours before operation, day 1 to day 7 post operation
Concentration of inflammatory cytokines and apelin in the cerebrospinal fluid.
Time Frame: day 0 (operation day)
day 0 (operation day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Vincent MINVILLE, MD, CHU Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2016

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 12, 2018

Study Registration Dates

First Submitted

August 26, 2015

First Submitted That Met QC Criteria

October 9, 2015

First Posted (Estimated)

October 12, 2015

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/14/7313

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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