HbA1c and Neurocognitive Disorders | NCT04736277

Studies
HbA1c and Neurocognitive Disorders

NCT04736277

Sponsor

University of Thessaly

Status

Unknown status

Last Update Posted

Oct 11, 2021Actual

Enrollment

288Estimated

Phase

Not provided

Conditions

Neurocognitive Disorders
HbA1c

Interventions

Preoperative HbA1c

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2015Actual

Primary Completion Date

Sep 1, 2021Actual

Completion Date

Nov 1, 2021Estimated

First Submitted Date

Oct 24, 2020

First Submission Date that Met QC Criteria

Feb 2, 2021

First Posted Date

Feb 3, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2021

Last Update Posted Date

Oct 11, 2021Actual

Name	Class
University Hospital, Ioannina	OTHER
Larissa University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Preliminary evidence suggest a possible relationship between HbA1c and perioperative neurocognitive disorders (NCD). We are going to investigate whether the preoperative value of HbA1c in patients undergoing elective non-cardiac surgery under general anesthesia, are related with increased risk of perioperative NCD.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

288Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Noncardiac surgery		Documentation of HbA1c in patients undergoing noncardiac surgery under general anesthesia	Other: Preoperative HbA1c

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Preoperative HbA1c	Other	Documentation of the preopetative HbA1c in patients undergoing noncardiac surgery under general anesthesia	Noncardiac surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Postoperative Neurocognitive Disorders assessed with CAM	Screening for POD assessed with CAM	1st postoperative day
Incidence of Postoperative Neurocognitive Disorders with IQCODE-16	Screening for POCD with IQCODE-16	10th postoperative day
Incidence of Postoperative Neurocognitive Disorders with IQCODE-16	Screening for POCD with IQCODE-16	3 months postoperatively
Incidence of Postoperative Neurocognitive Disorders with IQCODE-16	Screening for POCD with IQCODE-16	6 months postoperatively
Incidence of Postoperative Neurocognitive Disorders with IQCODE-16	Screening for POCD with IQCODE-16	9 months postoperatively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1) 45 - 80 years
2) American Society of Anesthesiologists physical status I to III
3) elective general, urological, gynecological and orthopedic surgery under general anesthesia
4) native speakers of the Greek language

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maria Ntalouka, MD, PhD	Contact	+306973688099		maria.ntalouka@icloud.com
Metaxia Bareka, MD, PhD	Contact	+306947845083		barekametaxia@hotmail.com

Overall Officials

Name	Affiliation	Role
Eleni Arnaoutoglou, MD, PhD	Professor of Anesthesiology	Study Chair
Maria Ntalouka, MD, PhD	Consultant of Anesthesiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Thessaly	Recruiting	Larissa		41335	Greece

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided