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

Primary Purpose

Delirium

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Determination of apelin and inflammatory cytokines
Assessment of cognitive functions
Liquid sampling cerebrospinal
Postoperative delirium research
Residual cognitive dysfunction research
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Delirium focused on measuring Postoperative cognitive disorders POCD, inflammation, Surgery

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • CHU Toulouse, service d'orthopédie et traumatologie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with orthopedic surgery

Arm 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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Evaluation of postoperative cognitive functions.
Evaluation with IQCODE questionary (Informant Questionary on Cognitive Decline in the Elderly)
Assessment of the autonomy.
Evaluation with IADL scale (Instrumental Activities Scale of Everyday Life)
Plasma concentration of apelin.
Plasma concentration of inflammatory cytokines.
Concentration of inflammatory cytokines and apelin in the cerebrospinal fluid.

Full Information

First Posted
August 26, 2015
Last Updated
August 13, 2018
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT02574234
Brief Title
Influence of Apelin Levels on Postoperative Cognitive Disorders After Orthopedic Surgery in Elderlies (APOCOGNIT)
Acronym
APOCOGNIT
Official Title
Influence of Apelin Levels on Postoperative Cognitive Disorders After Orthopedic Surgery in Elderlies
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 30, 2016 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
No

5. Study Description

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…).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
Postoperative cognitive disorders POCD, inflammation, Surgery

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with orthopedic surgery
Arm Type
Experimental
Arm 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)
Intervention Type
Other
Intervention Name(s)
Determination of apelin and inflammatory cytokines
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Assessment of cognitive functions
Intervention Description
Evaluation of preoperative cognitive performance by achieving a IQCODE, an MMS and an IADL scale.
Intervention Type
Other
Intervention Name(s)
Liquid sampling cerebrospinal
Intervention Description
Determination of the concentrations of inflammatory cytokines and apelin in cerebrospinal fluid perioperatively.
Intervention Type
Other
Intervention Name(s)
Postoperative delirium research
Intervention Description
Using the scale Confusion Assessment Method (CAM) for screening and delirium diagnosis. This research will be daily lasted, during the first 7 days postoperative.
Intervention Type
Other
Intervention Name(s)
Residual cognitive dysfunction research
Intervention Description
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 Outcome Measure Information:
Title
Postoperative delirium occurrence.
Description
Evaluation of the occurrence of postoperative delirium evaluated by the Confusion Assessment Method (CAM)
Time Frame
day1 to day 7 post-operation
Secondary Outcome Measure Information:
Title
Evaluation of postoperative cognitive functions.
Description
Evaluation with IQCODE questionary (Informant Questionary on Cognitive Decline in the Elderly)
Time Frame
day 1 to day 7 and 3 month after post-operation
Title
Assessment of the autonomy.
Description
Evaluation with IADL scale (Instrumental Activities Scale of Everyday Life)
Time Frame
day 1 to day 7 and 3 month after post-operation
Title
Plasma concentration of apelin.
Time Frame
day 1 to day 7 post operation
Title
Plasma concentration of inflammatory cytokines.
Time Frame
24 hours before operation, day 1 to day 7 post operation
Title
Concentration of inflammatory cytokines and apelin in the cerebrospinal fluid.
Time Frame
day 0 (operation day)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent MINVILLE, MD
Organizational Affiliation
CHU Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Toulouse, service d'orthopédie et traumatologie
City
Toulouse
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17325520
Citation
Silverstein JH, Timberger M, Reich DL, Uysal S. Central nervous system dysfunction after noncardiac surgery and anesthesia in the elderly. Anesthesiology. 2007 Mar;106(3):622-8. doi: 10.1097/00000542-200703000-00026. No abstract available.
Results Reference
background
PubMed Identifier
20007989
Citation
Deiner S, Silverstein JH. Postoperative delirium and cognitive dysfunction. Br J Anaesth. 2009 Dec;103 Suppl 1(Suppl 1):i41-46. doi: 10.1093/bja/aep291.
Results Reference
background
PubMed Identifier
18156877
Citation
Price CC, Garvan CW, Monk TG. Type and severity of cognitive decline in older adults after noncardiac surgery. Anesthesiology. 2008 Jan;108(1):8-17. doi: 10.1097/01.anes.0000296072.02527.18.
Results Reference
background
PubMed Identifier
22762316
Citation
Saczynski JS, Marcantonio ER, Quach L, Fong TG, Gross A, Inouye SK, Jones RN. Cognitive trajectories after postoperative delirium. N Engl J Med. 2012 Jul 5;367(1):30-9. doi: 10.1056/NEJMoa1112923.
Results Reference
background
PubMed Identifier
20818791
Citation
Cibelli M, Fidalgo AR, Terrando N, Ma D, Monaco C, Feldmann M, Takata M, Lever IJ, Nanchahal J, Fanselow MS, Maze M. Role of interleukin-1beta in postoperative cognitive dysfunction. Ann Neurol. 2010 Sep;68(3):360-8. doi: 10.1002/ana.22082.
Results Reference
background

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

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