Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:50 PM
Study NCT ID:
NCT06351956
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
New Onset Cardiac Arrhythmias in Septic Patients in Critical Care Setting, Predictors and Outcomes.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-04', 'studyFirstSubmitDate': '2024-03-02', 'studyFirstSubmitQcDate': '2024-04-04', 'lastUpdatePostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Risk Factors of cardiac arrhythmias in septic patients in CU.', 'timeFrame': '3 week from admission in CU', 'description': 'any medical condition precipitate the occurrence of cardiac arrhythmia'}, {'measure': 'Fates of cardiac arrhythmia.', 'timeFrame': '1 month from the primary endpoint', 'description': 'what complications will precipitate the arrhythmia or the recovery achievement'}], 'secondaryOutcomes': [{'measure': 'The frequent type of arrhythmias.', 'timeFrame': '2 years from starting collaboration', 'description': 'the most frequent type of cardiac arrhythmia'}, {'measure': 'Mortality rate due to new onset arrhythmia.', 'timeFrame': '2 years from starting collaboration', 'description': 'the number of deaths from the enrolled patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiac arrhythmia', 'sepsis', 'critical care'], 'conditions': ['Cardiac Arrhythmia']}, 'referencesModule': {'references': [{'pmid': '28523143', 'type': 'RESULT', 'citation': 'Marik PE, Taeb AM. SIRS, qSOFA and new sepsis definition. J Thorac Dis. 2017 Apr;9(4):943-945. doi: 10.21037/jtd.2017.03.125. No abstract available.'}, {'pmid': '24814972', 'type': 'RESULT', 'citation': 'Makrygiannis SS, Margariti A, Rizikou D, Lampakis M, Vangelis S, Ampartzidou OS, Katsifa K, Tselioti P, Foussas SG, Prekates AA. Incidence and predictors of new-onset atrial fibrillation in noncardiac intensive care unit patients. J Crit Care. 2014 Aug;29(4):697.e1-5. doi: 10.1016/j.jcrc.2014.03.029. Epub 2014 Apr 4.'}]}, 'descriptionModule': {'briefSummary': 'New Onset Cardiac Arrhythmias in Septic Patients in Critical Care Setting, Predictors and Outcomes', 'detailedDescription': 'Sepsis is recently defined as life-threatening condition caused by dysregulated body response to infection leading to organ dysfunction and even death. Patients who are vulnerable to catch sepsis are those with immune-compromising diseases, old aged people and chronic medical condition such as diabetes, chronic kidney diseases or cancer. Sepsis is symptomized by fever or hypothermia, tachycardia, tachypnea. In critical care units, septic patient are predisposed to have different cardiovascular manifestation as atrial fibrillation, atrial flutter, hypotension, etc. . Many studies reported the association between atrial fibrillation and septic patients in critical care as a complication of sepsis; but data regarding factors and fates is still insufficient. So in this study we aim to observe critical ill patients with sepsis to assess and evaluate the predisposing factors leading to new onset of cardiac arrhythmia in septic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients aged from 18 years and above of both sexes (male and female) who are admitted in critical care unit in Assuit University Hospital and diagnosed by sepsis will be enrolled if matched the eligibility criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient of 18 years old and above of both gender admitted with manifestation of sepsis.\n\nExclusion Criteria:\n\n* Patients below 18 years old.\n* Pregnant females.\n* Patients with cardiac arrhythmia before admission in the critical unit.\n* Patients with previous cardiac surgery.'}, 'identificationModule': {'nctId': 'NCT06351956', 'briefTitle': 'New Onset Cardiac Arrhythmias in Septic Patients in Critical Care Setting, Predictors and Outcomes.', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'New Onset Cardiac Arrhythmias in Septic Patients in Critical Care Setting, Predictors and Outcomes.', 'orgStudyIdInfo': {'id': 'Arrhythmias in Septic Patients'}}, 'contactsLocationsModule': {'centralContacts': [{'name': "Dina Sameh, Bachelor's", 'role': 'CONTACT', 'email': 'dinakoka96@gmail.com', 'phone': '01211947776'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Dina Sameh Anwer', 'investigatorAffiliation': 'Assiut University'}}}}