The Relationship Between Anticholinergic Burden and Posto... | NCT05312684

Studies
The Relationship Between Anticholinergic Burden and Postoperative Complications After Cardiac Surgery in Older Adults

NCT05312684

Sponsor

Gulhane Training and Research Hospital

Status

Unknown status

Last Update Posted

Apr 5, 2022Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Postoperative Complications

Interventions

cardiac surgery

Countries

Turkey (Türkiye)

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

Mar 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2022Estimated

Primary Completion Date

Sep 1, 2022Estimated

Completion Date

Dec 1, 2022Estimated

First Submitted Date

Mar 28, 2022

First Submission Date that Met QC Criteria

Mar 28, 2022

First Posted Date

Apr 5, 2022Actual

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

Mar 28, 2022

Last Update Posted Date

Apr 5, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bilal Katipoglu, M.D, Gulhane Training and Research HospitalPrincipal Investigator

Lead Sponsor

Gulhane Training and Research HospitalOTHER_GOV

Collaborators

Not provided

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

Drugs with anticholinergic properties are widely prescribed in the elderly population, despite increasing evidence in the literature regarding side effects and adverse outcomes. As is known, many drugs have anticholinergic activity, which means that they block the binding of the neurotransmitter acetylcholine to the muscarinic receptor. In this case, the occurrence of anticholinergic side effects becomes inevitable. Central effects such as cognitive impairment, dizziness, sedation, confusion or delirium, and peripheral effects such as dry mouth, dry eyes, constipation, urinary retention, and tachycardia begin to be seen in patients. Anticholinergic load refers to the cumulative effect of taking one or more drugs with anticholinergic activity. This cumulative effect is a strong indicator of cognitive and physical deterioration, especially in the elderly population. It is also associated with adverse outcomes such as falls, impaired functioning, and higher rates of hospitalization and death.

Anticholinergic load scales include scales that facilitate the work of physicians used in clinical practice to predict anticholinergic side effects in humans. Although there are many different scales used at this point, one of the scales with the highest validity and reliability in recent studies are Anticholinergic cognitive burden scale (ACB) and Anticholinergic risk scale (ARS). To the best of our knowledge, we could not find any study on postoperative complications, length of hospital stay and mortality after cardiac surgery with these scales. Therefore, we aimed to examine the relationship between possible complications after cardiac surgery and anticholinergic load scales showing the cumulative effect of preoperative drugs.

Detailed Description

Not provided

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

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High anticholinergic burden		ACB scale score 1 or >1 as a high anticholinergic buden	Procedure: cardiac surgery
Normal anticholinergic burden		ACB scale score <1 as a control group	Procedure: cardiac surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cardiac surgery	Procedure	cardiovascular surgery including valve repair/replacement or CABG or combined procedures	High anticholinergic burden Normal anticholinergic burden

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative complication	Dindo classification	1 month fellow-up

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

It is planned to include patients over the age of 65 who underwent cardiac surgery in the research population.
Gender discrimination will not be considered.

Exclusion Criteria:

Those who are under the age of 65,
Those who have non-cardiac surgery,
Those whose drug records cannot be accessed

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

100 Years

Standard Ages

Older Adult

Study Population

It is planned to include patients over the age of 65 who underwent cardiac surgery in the study population.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bilal Katipoglu, MD	Contact	+905543330380		drbilal07@gmail.com

Overall Officials

Name	Affiliation	Role
Bilal Katipoglu	Gulhane Training and Research Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gulhane training and research hospital		Ankara		06670	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37999982	Derived	Katipoglu B, Kurtbeyoglu S, Demir ZA, Mavioglu HL. The effect of the anticholinergic burden on mortality following elective cardiac surgery. Curr Med Res Opin. 2024 Jan;40(1):27-34. doi: 10.1080/03007995.2023.2288278. Epub 2024 Jan 3.

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative
D019616	Thoracic Surgical Procedures