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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06349057
Other study ID # AnkaraCHBilkent.1
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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