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

March 28, 2022 updated by: Bilal Katipoglu, Gulhane Training and Research Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

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

  • Turkey
      • Ankara, Turkey, 06670
        • Gulhane Training and Research Hospital

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

Ages Eligible for Study

65 years to 100 years (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
High anticholinergic burden
ACB scale score 1 or >1 as a high anticholinergic buden
Procedure: cardiac surgery
cardiovascular surgery including valve repair/replacement or CABG or combined procedures
Normal anticholinergic burden
ACB scale score <1 as a control group
Procedure: cardiac surgery
cardiovascular surgery including valve repair/replacement or CABG or combined procedures

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Gulhane Training and Research Hospital

Investigators

  • Principal Investigator: Bilal Katipoglu, Gulhane Training and Research Hospital

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 (ANTICIPATED)

April 1, 2022

Primary Completion (ANTICIPATED)

September 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

March 28, 2022

First Submitted That Met QC Criteria

March 28, 2022

First Posted (ACTUAL)

April 5, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 5, 2022

Last Update Submitted That Met QC Criteria

March 28, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-2476

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.

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