NCT05312684

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

March 28, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

April 5, 2022

Status Verified

March 1, 2022

Enrollment Period

5 months

First QC Date

March 28, 2022

Last Update Submit

March 28, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative complication

    Dindo classification

    1 month fellow-up

Study Arms (2)

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

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

High anticholinergic burdenNormal anticholinergic burden

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane training and research hospital

Ankara, 06670, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Postoperative Complications

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Bilal Katipoglu

    Gulhane Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bilal Katipoglu, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D

Study Record Dates

First Submitted

March 28, 2022

First Posted

April 5, 2022

Study Start

April 1, 2022

Primary Completion

September 1, 2022

Study Completion

December 1, 2022

Last Updated

April 5, 2022

Record last verified: 2022-03

Locations