The Effect of the Anticholinergic Burden Following Elective Coronary Artery Surgery

Postoperative Complications Clinical Trial

Official title:

The Effect of the Anticholinergic Burden on Complications and Mortality Following Elective Coronary Artery Surgery in Patients Over 60 Years

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06349057
• Other study ID #: AnkaraCHBilkent.1
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: Ankara City Hospital Bilkent
• Contact: Seda Kurtbeyoglu, DOCTOR
• Phone: +905388342776
• Email: kurtbeyogluseda[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 30, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mortality
• Postoperative Complications

Intervention

Drug:
• reducing anticholinergic burden
In the intraoperative and postoperative periods instead of drugs with high anticholinergic burden; drugs with low burden will be preferred.

Locations

Country	Name	City	State
Turkey	Seda Kurtbeyoglu	Çankaya	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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 — View 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of stay in hospital and intensive care unit	we will record days	Postoperative 90 days
Primary	Mortality	The patient will be visited every day during his/her stay in the hospital, and then the patient will be contacted by phone on the 90th day.Patient information will be checked from the hospital database.	Postoperative 90 days
Secondary	Effects on postoperative recovery	Daily living and the recovery processes of the patients in both preoperative and the postoperative period will be recorded using The Katz Activities of Daily Living Scale it measures six activities : continence, bathing, dressing, toileting, transferring (from one surface to another), and feeding. Each activity is graded on a scale of 0 (dependence) to 1 (independence). Calculates total score.; 0-2: dependent 3-4: partially dependent 5-6:independent	preoperative and postoperative 90 days
Secondary	Effects on postoperative recovery	Fraility and the recovery processes of the patients in both preoperative and the postoperative period will be recorded using The Clinical Frailty Scale (which is a nine-point scale based on clinical evaluation of mobility, energy, physical activity, and function.; 1-Very Fit 2 -Well 3-Managing Well 4 -Vulnerable 5 -Mildly Frail 6-Moderately Frail 7-Severely Frail 8-Very Severely Frail 9-Terminally Ill	Postoperative 90 days
Secondary	Postoperative complication	It will be monitored whether complications develop and reported if tehy occur, within 90 days.; Cardiac arrest,; Cardiac reoperation for bleeding; Cardiac reoperation other than bleeding; Deep sternal wound infection; Stroke (ischemic/hemorrhagic); Pneumonia / Pulmonary edema / Pleural effusion; Infection (urinary infection,wound infection, catheter infection, meningitis, mediastinitis, sepsis); Acute renal failure (to be assessed by the KDIGO criteria; increase in sCr =0.3 mg/dL (=26.5 µmol/L) within 48 hours; or increase in sCr =1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or 3 Urine volume <0.5 mL/kg/h for 6 hours); The patient will be visited every day during his/her stay in the hospital, and then the patient will be contacted by phone on the 90th day. Patient information will be checked from the hospital database.	Postoperative 90 days