NCT02574234

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 12, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

March 30, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2018

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

1.9 years

First QC Date

August 26, 2015

Last Update Submit

February 23, 2024

Conditions

Delirium

Keywords

Postoperative cognitive disorders POCDinflammationSurgery

Outcome Measures

Primary Outcomes (1)

  • Postoperative delirium occurrence.

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

    day1 to day 7 post-operation

Secondary Outcomes (5)

  • Evaluation of postoperative cognitive functions.

    day 1 to day 7 and 3 month after post-operation

  • Assessment of the autonomy.

    day 1 to day 7 and 3 month after post-operation

  • 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)

Study Arms (1)

Patients with orthopedic surgery

EXPERIMENTAL

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 cytokinesOther: Assessment of cognitive functionsOther: Liquid sampling cerebrospinalOther: Postoperative delirium researchOther: Residual cognitive dysfunction research

Interventions

Determination of apelin and inflammatory cytokinesOTHER

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.

Patients with orthopedic surgery
Assessment of cognitive functionsOTHER

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

Patients with orthopedic surgery
Liquid sampling cerebrospinalOTHER

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

Patients with orthopedic surgery
Postoperative delirium researchOTHER

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

Patients with orthopedic surgery
Residual cognitive dysfunction researchOTHER

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.

Patients with orthopedic surgery

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients submitted to a programed orthopedic surgery
  • Patients with pre- and post-surgery check-up.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Toulouse, service d'orthopédie et traumatologie

Toulouse, France

Location

Related Publications (6)

  • 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.

    PMID: 17325520BACKGROUND

  • 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.

    PMID: 20007989BACKGROUND

  • 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.

    PMID: 18156877BACKGROUND

  • 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.

    PMID: 22762316BACKGROUND

  • 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.

    PMID: 20818791BACKGROUND

  • Labaste F, Delort F, Ferre F, Bounes F, Reina N, Valet P, Dray C, Minville V. Postoperative delirium is a risk factor of institutionalization after hip fracture: an observational cohort study. Front Med (Lausanne). 2023 Aug 15;10:1165734. doi: 10.3389/fmed.2023.1165734. eCollection 2023.

    PMID: 37649978RESULT

MeSH Terms

Conditions

DeliriumInflammation

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersPathologic Processes

Study Officials

  • Vincent MINVILLE, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2015

First Posted

October 12, 2015

Study Start

March 30, 2016

Primary Completion

March 1, 2018

Study Completion

March 12, 2018

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)