NLR and PRL in Neurocognitive Disorders

April 27, 2021 updated by: Elena Arnaoutoglou, University of Thessaly

The Effect of NLR and PLR on Perioperative Neurocognitive Disorders in Patients Undergoing Elective Non-cardiac Surgery Under General Anesthesia.

Preliminary evidence suggest a possible relationship between Neutrophil-Lymphocyte Ratio (NLR) and Platelet-Lymphocyte Ratio (PLR) and perioperative neurocognitive disorders (NCD). We are going to investigate whether the values of NLR and PLR in patients undergoing elective non-cardiac surgery under general anesthesia, are related with increased risk of perioperative NCD.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

It is estimated that approximately 10% of elderly undergoing surgery will develop cognitive changes perioperatively, while in some reports the incidence rises up to 80%. Despite the reported high prevalence of perioperative neurocognitive disorders (NCD), their exact etiology is still largely unknown.

Preliminary evidence suggest a possible relationship between Neutrophil-Lymphocyte Ratio (NLR) and Platelet-Lymphocyte Ratio (PLR) and perioperative neurocognitive disorders (NCD). We are going to investigate whether the values of NLR and PLR in patients undergoing elective non-cardiac surgery under general anesthesia, are related with increased risk of perioperative NCD.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
288

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

  • Greece
      • Larissa, Greece, 41335
        • Recruiting
        • University of Thessaly
        • Sub-Investigator:
          • Petros Tzimas, MD, PhD
        • Sub-Investigator:
          • Alexandros Brotis, MD, PhD
        • Sub-Investigator:
          • Fragkiskos Angelis, MD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

41 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients 45 - 80 years old, ASA I-III undergoing elective general, urological, gynecological and orthopedic surgery under general anesthesia.

Description

Inclusion Criteria:

  • 45 - 80 years
  • American Society of Anesthesiologists physical status I to III
  • elective general, urological, gynecological and orthopedic surgery under general anesthesia
  • native speakers of the Greek language

Exclusion Criteria:

  • refused to participate or sign the informed consent form
  • had undergone surgery or anesthesia within the last 30 days
  • had any prior or current history involving an affliction of the central nervous system
  • were diagnosed with severe cognitive decline based on the 16 - item Informant Questionnaire on Cognitive Decline (IQCODE - 16)
  • suffered from severe hearing or visual impairment
  • any psychiatric disorder
  • had a score >5 in the Geriatric Depression Scale (GDS - 15)
  • or a score in females < 4 males < 2 in the Lawton - Brody Instrumental Activities of Daily Living Scale (I.A.D.L.)
  • reported alcohol consumption > 35 units/week
  • drug dependence
  • had undergone previous neuropsychological testing
  • Diabetes Mellitus type II with > 10 years of diagnosis
  • Diabetes Mellitus type I
  • Hemoglobin A1c (HbA1c) > 7.5%
  • suffered from hemodynamical instability (> 20% alterations of blood pressure perioperatively)
  • or desaturation (one or more events of SpO2 < 80% for more than 2 minutes) peri-operatively
  • or blood loss of more than one unit

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

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Noncardiac surgery
Calculation of the NLR and PLR in patients undergoing noncardiac surgery under general anesthesia
Other: NLR
Calculation of NLR
Other: PLR
Calculation of PLR

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Postoperative neurocognitive disorders assessed with CAM
Time Frame: 1st postoperative day
Incidence of POD assessed with CAM
1st postoperative day
Incidence of Postoperative neurocognitive disorders assessed with IQCODE-16
Time Frame: 10th postoperative day
Incidence of POCD assessed with IQCODE-16
10th postoperative day
Incidence of Postoperative neurocognitive disorders assessed with IQCODE-16
Time Frame: 3 months postoperatively
Incidence of POCD assessed with IQCODE-16
3 months postoperatively
Incidence of Postoperative neurocognitive disorders assessed with IQCODE-16
Time Frame: 6 months postoperatively
Incidence of POCD assessed with IQCODE-16
6 months postoperatively
Incidence of Postoperative neurocognitive disorders assessed with IQCODE-16
Time Frame: 9 months postoperatively
Incidence of POCD assessed with IQCODE-16
9 months postoperatively

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Thessaly

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Larissa University Hospital
University Hospital, Ioannina

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Eleni Arnaoutoglou, MD, PhD, Professor of Anesthesiology
  • Principal Investigator: Maria Ntalouka, MD, PhD, Consultant of Anesthesiology

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NLR, PLR and NCD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Neurocognitive Disorders

Clinical Trials on NLR

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings