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

What Was Tested

In this not phased trial, researchers set out to test Apelin.

This project propose to measure plasma levels of apelin in wide population submitted to orthopedic surgery.

Apelin could be involved in anti-inflammatory processes.

It had 1 arm (groups): Patients with orthopedic surgery (experimental).

The registry classes the interventions as other.

More on the Plan

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.

Who Took Part

The registry lists 88 actual participants took part.

It was open to people of any sex aged from 75 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients submitted to a programed orthopedic surgery. Patients with pre- and post-surgery check-up.

The full record lists 2 inclusion and 5 exclusion criteria; among the exclusions: non programed orthopedic surgery (emergency); patients with sepsis; patients submitted to orthopedic surgery but with ambulatory management.

How the Study Was Run

The set-up was single-group and open-label.

Everyone knew when Apelin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2016-03-30 with completion listed for 2018-03.

It ran at 1 site in France.

Its stated primary purpose is diagnostic.

What Was Measured

Researchers chose this as the main measure: Postoperative delirium occurrence (time frame: day1 to day 7 post-operation).

It also tracked 5 secondary outcomes, for example Evaluation of postoperative cognitive functions, Assessment of the autonomy, Plasma concentration of apelin, Plasma concentration of inflammatory cytokines and Concentration of inflammatory cytokines and apelin in the cerebrospinal fluid.

What This Means in Plain Language

Put simply, this is a not phased trial of Apelin in 88 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Apelin compound page, all human trials.