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

NCT ID: NCT05312684

Last Updated: 2022-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2022-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High anticholinergic burden

ACB scale score 1 or \>1 as a high anticholinergic buden

cardiac surgery

Intervention Type PROCEDURE

cardiovascular surgery including valve repair/replacement or CABG or combined procedures

Normal anticholinergic burden

ACB scale score \<1 as a control group

cardiac surgery

Intervention Type PROCEDURE

cardiovascular surgery including valve repair/replacement or CABG or combined procedures

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cardiac surgery

cardiovascular surgery including valve repair/replacement or CABG or combined procedures

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

65 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gulhane Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Bilal Katipoglu

M.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bilal Katipoglu

Role: PRINCIPAL_INVESTIGATOR

Gulhane Training and Research Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gulhane training and research hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Bilal Katipoglu, MD

Role: CONTACT

+905543330380

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Bilal Katipoglu, MD

Role: primary

+905543330380

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 37999982 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

22-2476

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.