Clinical trial NCT06349057: The Effect of the Anticholinergic Burden Following Elective Coronary Artery Surgery
Official title: The Effect of the Anticholinergic Burden on Complications and Mortality Following Elective Coronary Artery Surgery in Patients Over 60 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mortality
Postoperative Complications
Keywords: cardiac surgery
anticholinergic burden
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many drugs have anticholinergic activity. This means that it blocks the muscarinic binding of the neurotransmitter acetylcholine.

In this study, the anticholinergic burden of the patients in the perioperative period will be calculated with the Anticholinergic Cognitive Burden Scale (ACBS) and patients with a score of 1 or above will be included in the study. Anticholinergic load of drugs used in the intraoperative period; Its effect on postoperative hospital stay, morbidity and mortality following elective heart surgery will be investigated.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective coronary artery bypass surgery
* Patients with high anticholinergic burden

Exclusion Criteria:

* All other procedures except isolated coronary bypass surgery
* Patients with low anticholinergic burden
* Patients whose records cannot be accessed through the data system

Primary outcomes:
measure: Mortality
timeFrame: Postoperative 90 days
Secondary outcomes:
measure: Effects on postoperative recovery
timeFrame: preoperative and postoperative 90 days
measure: Effects on postoperative recovery
timeFrame: Postoperative 90 days
measure: Postoperative complication
timeFrame: Postoperative 90 days
Other outcomes:
measure: Length of stay in hospital and intensive care unit
timeFrame: Postoperative 90 days
Locations:
city: Çankaya
country: Turkey
facility: Seda Kurtbeyoğlu
state: Ankara
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Seda Kurtbeyoğlu, DOCTOR
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hebert M, Cartier R, Dagenais F, Langlois Y, Coutu M, Noiseux N, El-Hamamsy I, Stevens LM. Standardizing Postoperative Complications-Validating the Clavien-Dindo Complications Classification in Cardiac Surgery. Semin Thorac Cardiovasc Surg. 2021 Summer;33(2):443-451. doi: 10.1053/j.semtcvs.2020.09.029. Epub 2020 Sep 24.
citation: Salahudeen MS, Hilmer SN, Nishtala PS. Comparison of anticholinergic risk scales and associations with adverse health outcomes in older people. J Am Geriatr Soc. 2015 Jan;63(1):85-90. doi: 10.1111/jgs.13206.
citation: Magin PJ, Morgan S, Tapley A, McCowan C, Parkinson L, Henderson KM, Muth C, Hammer MS, Pond D, Mate KE, Spike NA, McArthur LA, van Driel ML. Anticholinergic medicines in an older primary care population: a cross-sectional analysis of medicines' levels of anticholinergic activity and clinical indications. J Clin Pharm Ther. 2016 Oct;41(5):486-92. doi: 10.1111/jcpt.12413. Epub 2016 Jun 27.