Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2026-02-11 @ 6:03 PM
Study NCT ID:
NCT06349057
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2024-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of the Anticholinergic Burden Following Elective Coronary Artery Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2024-03-17', 'studyFirstSubmitQcDate': '2024-04-04', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Katz Index of Independence in Activities of Daily Living and Clinical Frailty Scale (CFS)', 'timeFrame': 'Postoperative day 90', 'description': 'The Katz Index of Independence in Activities of Daily Living evaluates a patient\'s ability to perform six basic functions: bathing, dressing, toileting, transferring, continence, and feeding. Each activity is scored as either "independent" (1 point) or "dependent" (0 points). The total score reflects the patient\'s overall level of functional independence.\n\nThe Clinical Frailty Scale (CFS) is a validated 9-point tool used to assess a patient\'s baseline frailty status. It evaluates physical fitness, comorbidity burden, functional dependence, and overall health status. Scores range from 1 (Very Fit) to 9 (Terminally Ill). Higher scores indicate greater frailty and worse baseline physiological reserve.'}], 'secondaryOutcomes': [{'measure': 'Intensive Care Unit Length of Stay (days)', 'timeFrame': 'From postoperative ICU admission until ICU discharge (typically within 1-3 days).', 'description': 'The duration of stay in the intensive care unit, measured in days, from ICU admission after surgery until ICU discharge.'}, {'measure': 'Duration of Mechanical Ventilation (hours)', 'timeFrame': 'From the end of surgery to extubation', 'description': 'The duration of postoperative mechanical ventilation, measured in hours, from end of surgery until successful extubation.'}, {'measure': 'other postoperative complications', 'timeFrame': 'From completion of surgery to postoperative day 90', 'description': 'Occurrence of postoperative complications within 90 days after surgery, including neurological (stroke, transient ischemic attack, seizures), renal (acute kidney injury, need for renal replacement therapy, chronic renal failure), and infectious complications (pneumonia, mediastinitis, meningitis, urinary tract infection, wound infection, catheter-related sepsis), as well as delirium.'}, {'measure': 'all-cause mortality', 'timeFrame': 'From completion of surgery to postoperative day 90', 'description': 'All-cause mortality occurring within 90 days after surgery.'}, {'measure': 'Change in Katz Index of Independence in Activities of Daily Living From Baseline', 'timeFrame': 'Baseline (preoperative) to postoperative day 90', 'description': 'The change in Katz Index score will be calculated as the postoperative day 90 score minus the preoperative baseline score. The Katz Index ranges from 0 (highly dependent) to 6 (independent). Higher scores indicate better functional independence.'}, {'measure': 'Postoperative major cardiac complications', 'timeFrame': 'From completion of surgery to postoperative day 90', 'description': 'Incidence of major postoperative cardiac complications, including cardiac arrest, myocardial infarction, arrhythmia, and aortic dissection.'}, {'measure': 'Hospital length of stay (days)', 'timeFrame': 'From hospital admission for surgery until hospital discharge (typically within 5-10 days).', 'description': 'Duration of postoperative hospital stay, measured in days, from admission to the hospital after surgery until hospital discharge.'}, {'measure': 'Incidence of major pulmonary complications', 'timeFrame': 'From completion of surgery to postoperative day 90', 'description': 'Major postoperative pulmonary complications, including pneumothorax, pleural effusion, pulmonary embolism, and acute respiratory distress syndrome (ARDS).'}, {'measure': 'Change in Clinical Frailty Scale (CFS) from baseline', 'timeFrame': 'Baseline (preoperative) to postoperative day 90', 'description': 'Change in Clinical Frailty Scale (CFS) score from preoperative baseline to postoperative day 90.\n\nThe CFS is a nine-point scale assessing mobility, energy, physical activity, and overall functional health:\n\n1. = Very Fit\n2. = Well\n3. = Managing Well\n4. = Vulnerable\n5. = Mildly Frail\n6. = Moderately Frail\n7. = Severely Frail\n8. = Very Severely Frail\n9. = Terminally Ill Higher scores indicate greater frailty.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiac surgery', 'anticholinergic burden', 'elderly', 'represcribing'], 'conditions': ['Postoperative Recovery', 'Length of Hospital Stay', 'Postoperative Complications']}, 'referencesModule': {'references': [{'pmid': '32979483', 'type': 'RESULT', '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.'}, {'pmid': '25597560', 'type': 'RESULT', '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.'}, {'pmid': '27349795', 'type': 'RESULT', '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."}]}, 'descriptionModule': {'briefSummary': 'Anticholinergic drugs are common in older adults and linked to cognitive decline, frailty, longer hospital stay, and higher mortality. This cumulative burden, often increased by anesthetics and analgesics, may worsen during surgery. The study evaluates whether reducing perioperative anticholinergic load improves recovery after cardiac surgery.', 'detailedDescription': 'Anticholinergic agents are frequently prescribed in older adults and have been linked to negative outcomes such as cognitive decline, frailty, extended hospitalization, and increased mortality. The cumulative exposure, referred to as anticholinergic burden, may be exacerbated during the perioperative period due to anesthetic and analgesic use. This trial explores whether minimizing perioperative anticholinergic burden can improve postoperative recovery following cardiac surgery. In this prospective, randomized controlled study, 120 patients aged 60 years or older undergoing isolated coronary artery bypass grafting with a preoperative Anticholinergic Cognitive Burden score of ≥3 were included. Participants were assigned either to standard perioperative care involving anesthetic and analgesic agents with anticholinergic activity (Group Standard) or to a deprescribing protocol excluding all anticholinergic drugs intraoperatively and postoperatively (Group Deprescribing). The primary endpoints were functional recovery assessed at 90 days using the Katz Index and Clinical Frailty Scale. Secondary endpoints comprised hospital length of stay, 90-day incidence of cardiac and pulmonary complications, intensive care Unit stay, duration of mechanical ventilation, additional complications, and 90-day mortality. The Wilcoxon signed-rank test was used for paired comparisons of Katz and frailty scores, while multivariate logistic regression was applied to identify independent predictors of postoperative cardiac complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing elective coronary artery bypass surgery\n* Patients with high anticholinergic burden\n\nExclusion Criteria:\n\n* All other procedures except isolated coronary bypass surgery\n* Patients with low anticholinergic burden\n* Patients whose records cannot be accessed through the data system'}, 'identificationModule': {'nctId': 'NCT06349057', 'briefTitle': 'The Effect of the Anticholinergic Burden Following Elective Coronary Artery Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Anticholinergic Burden as a Modifiable Risk Factor in Cardiac Surgery: Evidence From a Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'AnkaraCHBilkent.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard of care', 'description': 'There will be no intervention in the perioperative period, data will be collected only by observation. Anesthesia management, surgical procedure and postoperative care will be applied as routine.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Remifentanyl, Propofol, Sevoflurane / Desflurane, Propofol', 'description': 'Preoperative period : There will be no intervention.\n\nIntraoperative period : An erector spinae plane block will be applied before anesthesia induction. Drugs with cholinergic burden will not be preferred. Lower anticholinergic drugs will be used. There will be no intervention in the surgical procedure.\n\nPostoperative period : Drugs with high cholinergic burden will not be used. Lower anticholinergic drugs will be used.\n\nIntraoperative and postoperative periods, instead of drugs with high anticholinergic burden; lower burden drugs will be preferred.\n\nHigh anticholinergic burden drugs: (Fentanyl -, Tramadol-, Midazolam , Pancuronium9\n\nLower burden drugs : (Remifentanyl, Sevoflurane, Desflurane, Propofol, Rocuronium, Lidocaine)', 'interventionNames': ['Drug: reducing anticholinergic burden']}], 'interventions': [{'name': 'reducing anticholinergic burden', 'type': 'DRUG', 'otherNames': ['not reducing anticholinergic burden, routine care'], 'description': 'In the intraoperative and postoperative periods instead of drugs with high anticholinergic burden; drugs with low burden will be preferred.', 'armGroupLabels': ['Remifentanyl, Propofol, Sevoflurane / Desflurane, Propofol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06800', 'city': 'Ankara', 'state': 'çankaya', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'aslihan aykut, specialist', 'role': 'CONTACT', 'email': 'asli_dncr@hotmail.com', 'phone': '+905325502013'}, {'name': 'zeliha asli demir, profesor', 'role': 'CONTACT', 'email': 'zaslidem@yahoo.com', 'phone': '05052491598'}], 'facility': 'Aslihan Aykut', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Aslıhan Aykut, specialist', 'role': 'CONTACT', 'email': 'asli_dncr@hotmail.com', 'phone': '+905325502013'}, {'name': 'muhammed çobas, specialist', 'role': 'CONTACT', 'email': 'mcobas7633@gmail.com', 'phone': '+95542693986'}], 'overallOfficials': [{'name': 'Aslıhan Aykut, specialist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara City Hospital Bilkent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Muhammed Çobas', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}