Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT04828902
Status:
UNKNOWN
Last Update Posted:
2021-04-15
First Post:
2021-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Incidence of Postoperative Delirium After Cardiac Surgery in Adults.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}, {'id': 'D001026', 'term': 'Coronary Artery Bypass'}, {'id': 'D016027', 'term': 'Heart Transplantation'}], 'ancestors': [{'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}, {'id': 'D009204', 'term': 'Myocardial Revascularization'}, {'id': 'D058017', 'term': 'Vascular Grafting'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D016377', 'term': 'Organ Transplantation'}, {'id': 'D014180', 'term': 'Transplantation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-12', 'studyFirstSubmitDate': '2021-03-21', 'studyFirstSubmitQcDate': '2021-03-30', 'lastUpdatePostDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delirium incidence and risk', 'timeFrame': 'Through hospitalisation in Postop-ICU - an average of 2 days', 'description': 'Incidence and risk of postoperative delirium'}, {'measure': 'Risk factors of delirium.', 'timeFrame': 'Through hospitalisation in Postop-ICU - an average of 2 days', 'description': 'collected will be known risk factors of delirium: schedule type, age, arterial hypertension, atrial fibrillation, BMI, ACE/ARBs therapy, hearing loss, dementia, peripheral artery disease, myocardial infarction, depression, diabetes, COVID19 and/or vaccination for it; and outcome data: hospital-LOS, prolonged sedation, antipsychotic therapy, surgical reintervention, direct coercion, length of mechanical ventilation, number of tracheal intubations, length of consciousness disorders, blood product transfusions, cardiopulmonary resuscitation, renal replacement therapy, mechanical circulatory support, duration of catecholamine support, ICU readmissions, new antibiotic therapies, 30-day mortality.'}, {'measure': 'Association between delirium and length of stay in ICU (LOS-ICU).', 'timeFrame': 'Through hospitalisation in Postop-ICU - an average of 2 days', 'description': 'Association between delirium and length of stay in ICU (LOS-ICU).'}], 'secondaryOutcomes': [{'measure': 'DOSS', 'timeFrame': 'Through hospitalisation in Postop-ICU - an average of 2 days', 'description': 'Associations between delirium and mean DOSS'}, {'measure': 'Hospital-LOS', 'timeFrame': 'Through hospitalisation in Postop-ICU - an average of 2 days', 'description': 'Association between delirium and hospital-LOS'}, {'measure': 'Prolonged sedation, antipsychotic therapy and surgical re-intervention.', 'timeFrame': 'Through hospitalisation in Postop-ICU - an average of 2 days', 'description': 'Association between delirium and prolonged sedation, antipsychotic therapy, surgical reintervention.'}, {'measure': 'Hours on ventilator.', 'timeFrame': 'Through hospitalisation in Postop-ICU - an average of 2 days', 'description': 'Association between delirium and HOV.'}, {'measure': 'Intubations', 'timeFrame': 'Through hospitalisation in Postop-ICU - an average of 2 days', 'description': 'Association between delirium and number of tracheal intubations.'}, {'measure': 'Consciousness disorders', 'timeFrame': 'Through hospitalisation in Postop-ICU - an average of 2 days', 'description': 'Association between delirium and length of consciousness disorders.'}, {'measure': 'Transfusions', 'timeFrame': 'Through hospitalisation in Postop-ICU - an average of 2 days', 'description': 'Association between delirium and blood product transfusions.'}, {'measure': 'CPR, RRT, MCS', 'timeFrame': 'Through hospitalisation in Postop-ICU - an average of 2 days', 'description': 'Association between delirium and CPR, RRT, and MCS.'}, {'measure': 'Catecholamines', 'timeFrame': 'Through hospitalisation in Postop-ICU - an average of 2 days', 'description': 'Association between delirium and duration of catecholamine support.'}, {'measure': 'ICU readmissions', 'timeFrame': 'Through hospitalisation in Postop-ICU - an average of 2 days', 'description': 'Association between delirium and ICU readmissions.'}, {'measure': 'New antibiotic', 'timeFrame': 'Through hospitalisation in Postop-ICU - an average of 2 days', 'description': 'Association between delirium and new antibiotic therapy.'}, {'measure': '30-day mortality', 'timeFrame': '30 days after operation', 'description': 'Association between delirium and 30-day mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postoperative delirium', 'cardiac surgery', 'Covid19'], 'conditions': ['Postoperative Delirium', 'Adult Cardiac Surgery', 'Covid19']}, 'descriptionModule': {'briefSummary': 'Postoperative delirium is an acute syndrome of mental deterioration characterized by acute onset and fluctuating course during the day. Very frequent delirium is a presage of other serious comorbidities i.e.: sepsis, acute kidney injury, circulatory and/or respiratory failure. A detailed knowledge of symptoms and early diagnose of delirium increase the chances of early therapy. To what extent the occurrence of postoperative delirium influences hospital therapy in the Cardiac Surgical Postoperative ICU in University Clinical Centre in Gdańsk is unknown so far.', 'detailedDescription': 'Study type: prospective, observational cohort study. Facility: tertiary, university hospital Methods: Patients will undergo routine, continuous observation for symptoms of delirium by a trained nursing staff. Occurrence of delirium, Delirium Observation Screening Scale (DOSS) grading, and therapy will by annotated on case record forms (CRFs) every 12 hours. Additionally, collected will be known risk factors of delirium: schedule type, age, arterial hypertension, atrial fibrillation, body mass index (BMI), angiotensin converting enzyme (ACE) inhibitors / angiotensin receptor blockers (ARBs) therapy, hearing loss, dementia, peripheral artery disease, myocardial infarction, depression, diabetes, corona virus disease 2019 (COVID19) infection and/or vaccination; and outcome data: hospital-LOS, prolonged sedation, antipsychotic therapy, surgical reintervention, hours on mechanical ventilation (HOV), number of tracheal intubations, length of consciousness disorders, blood product transfusions, cardiopulmonary resuscitation (CPR), renal replacement therapy (RRT), mechanical circulatory support (MCS), duration of catecholamine support, ICU readmissions, new antibiotic therapies, 30-day mortality.\n\nStatistical methods: Delirium morbidity and risk will be calculated from two-by-two table. Associations between delirium and secondary outcome measures will be evaluated by simple and logistic regression with use of ANOVA test for continuous variables with homogeneous distribution, or Kruskal-Wallis test for continuous variables with non-homogeneous distribution, or categorical variables. Significant will be considered results with p\\<0.05.\n\nA period of one year was assumed sufficient to draw conclusions on the primary endpoints of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients undergoing elective/emergency cardiac surgery will be considered eligible.', 'genderDescription': 'Gender will be reported as declared by the subjects.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (\\>18 y.a.), undergoing cardiac surgery, who will sign an informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Deny to sign or absence of an informed consent.'}, 'identificationModule': {'nctId': 'NCT04828902', 'briefTitle': 'Incidence of Postoperative Delirium After Cardiac Surgery in Adults.', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Gdansk'}, 'officialTitle': 'Incidence of Postoperative Delirium After Cardiac Surgery in Adults - a Prospective Observational Cohort Study', 'orgStudyIdInfo': {'id': 'NKBBN/4421/2020'}}, 'armsInterventionsModule': {'interventions': [{'name': 'cardiac surgery', 'type': 'PROCEDURE', 'otherNames': ['cabg', 'valve surgery', 'aorta surgery', 'heart transplant', 'other cardiac surgery'], 'description': 'Any heart surgery on or without cardiopulmonary bypass performed under general anesthesia in the Cardiac Surgical Department, Medical University of Gdańsk.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80-211', 'city': 'Gdansk', 'state': 'Pomeranian Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Maciej M Kowalik, Dr hab.', 'role': 'CONTACT', 'email': 'mkowalik@gumed.edu.pl', 'phone': '+48585844209'}, {'name': 'Paweł Kozak, Mgr. piel.', 'role': 'CONTACT', 'email': 'Paweł.kozak@gumed.edu.pl', 'phone': '+48585844208'}, {'name': 'Maciej M Kowalik, M.D., Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Paweł Kozak, Mgr. Piel.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Cadiac Anesthesiology, Medical University of Gdańsk', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}], 'centralContacts': [{'name': 'Maciej M Kowalik, Dr. hab.', 'role': 'CONTACT', 'email': 'mkowalik@gumed.edu.pl', 'phone': '+48585844209'}, {'name': 'Paweł Kozak, Mgr. Piel.', 'role': 'CONTACT', 'email': 'Paweł.kozak@gumed.edu.pl', 'phone': '+48585844208'}], 'overallOfficials': [{'name': 'Romuald Lango, Prof.dr.hab.', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical University of Gdańsk, Department of Cardiac Anesthesiology'}, {'name': 'Maciej Kowalik, Dr hab.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical University of Gdańsk, Department of Cardiac Anesthesiology'}, {'name': 'Pawel Kozak, Mgr. Piel.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Gdańsk, Department of Cardiac Anesthesiology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Anonymized patients data are planned to be uploaded into a public data repository (ZENODO.com) after data completion.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Gdansk', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Promotor, Dr hab. n. med. Maciej Michał Kowalik', 'investigatorFullName': 'Maciej M. Kowalik, MD, PhD', 'investigatorAffiliation': 'Medical University of Gdansk'}}}}