Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2025-12-28 @ 9:39 PM
Study NCT ID:
NCT06187168
Status:
RECRUITING
Last Update Posted:
2024-01-25
First Post:
2023-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Factors of Post-ERCP Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002760', 'term': 'Cholangiopancreatography, Endoscopic Retrograde'}], 'ancestors': [{'id': 'D002758', 'term': 'Cholangiography'}, {'id': 'D011860', 'term': 'Radiography, Abdominal'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-24', 'studyFirstSubmitDate': '2023-12-17', 'studyFirstSubmitQcDate': '2023-12-17', 'lastUpdatePostDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-ERCP Sepsis', 'timeFrame': '24 hours after ERCP', 'description': 'Definition: SOFA score ≥ 2 or increase in the SOFA score by ≥ 2 from the baseline SOFA score ≥ 2 or increase in the SOFA score by ≥ 2 from the baseline (dicotomus outcome: yes or no)'}], 'secondaryOutcomes': [{'measure': 'Hospital readmission', 'timeFrame': '30 days after ERCP', 'description': 'Hospital readmission (dicotomus outcome: yes or no)'}, {'measure': 'Post-ERCP ICU admission', 'timeFrame': '7 days after ERCP', 'description': 'post-ERCP admission to the ICU for any cause (dicotomus outcome: yes or no)'}, {'measure': 'Length of hospital stay', 'timeFrame': '30 days after ERCP', 'description': 'in days (continuous outcome)'}, {'measure': 'Postoperative bacteremia', 'timeFrame': '24 hours after surgery', 'description': 'Bactermia on blood culture (post-ERCP in comparison to the pre-ERCP blood culture): (dicotomus outcome: yes or no)'}, {'measure': 'Post-ERCP pancreatitis', 'timeFrame': '24 hours after ERCP', 'description': 'Raised lipases and amylase (dicotomus outcome: yes or no)'}, {'measure': 'Post-ERCP RBCs transfusion', 'timeFrame': '24 hours after ERCP', 'description': 'any amount of red blood tranfusion after the ERCP (dicotomus outcome: yes or no)'}, {'measure': '30-day all-cause mortality', 'timeFrame': '30 days after ERCP', 'description': 'Death of any cause (dicotomus outcome: yes or no)'}, {'measure': 'Delayed post-ERCP Sepsis', 'timeFrame': '7 days after ERCP procedure', 'description': 'SOFA score ≥ 2 or increase in the SOFA score by ≥ 2 from the baseline (dicotomus outcome: yes or no)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis', 'Intraoperative Hypotension', 'Bacteremia Sepsis']}, 'descriptionModule': {'briefSummary': "For the treatment of numerous biliary and pancreatic problems, the procedure known as endoscopic retrograde cholangiopancreatography (ERCP) is regarded as a crucial therapeutic intervention. However, ERCP is known to be connected to a variety of issues, including post-ERCP sepsis. This study's goal is to investigate the relationship between unexplained hypotension during or just after surgery and the emergence of sepsis after ERCP.", 'detailedDescription': "At the Gastrointestinal Surgery Centre, Mansura University, Egypt, a cohort study will be conducted on a sample of 50 adult (18+) patients who undergoing ERCP. Hypotension that occurred during surgery or shortly after will be classified as exposure when it cannot be linked to a particular cause. In this study, post-ERCP sepsis will be the major outcome measure, while other ERCP-related sequelae will be the supplementary outcome measures.\n\nDiscussion:\n\nThe findings of this study will significantly advance our understanding of the potential link between intraoperative hypotension and the development of post-ERCP sepsis. This study's goal is to increase knowledge of the challenges presented by ERCP, which will aid in the creation of patient treatment methods that are more effective."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include 100 adult patients (≥ 18years) undergoing ERCP for obstructive jaundice at the GISC during the study period for obstructive jaundice.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing ERCP for obstructive jaundice\n* Adult (Older than 18 years old)\n* Written Informed Consent\n\nExclusion Criteria:\n\n* Already on sepsis before the ERCP\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT06187168', 'briefTitle': 'Risk Factors of Post-ERCP Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Intra-operative Hypotension and Sepsis After Endoscopic Retrograde Cholangiopancreatography: A Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'R.23.11.2387'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'intraoperative hypotension', 'description': 'The exposure is intra-operative hypotension during the ERCP procedure (hypotension is defined as a 20% reduction in the mean arterial blood pressure (MAP) or systolic arterial blood pressure (SAP) \\< 90 mmHg during CBD manipulation or after obstruction relief). The basal blood pressure (BP) will be the immediate reading before the endoscope insertion while the patient is in his left lateral position.', 'interventionNames': ['Procedure: exposure to hypotension during the Endoscopic Retrograde Cholangiopancreatography (ERCP) for obstructive jundice.']}, {'label': 'No intraoperative hypotension', 'description': 'Not meeting the above definition of hypotension per our protocol (by timing, threshold, and method).'}], 'interventions': [{'name': 'exposure to hypotension during the Endoscopic Retrograde Cholangiopancreatography (ERCP) for obstructive jundice.', 'type': 'PROCEDURE', 'description': 'This is not an intended intervention in the study. This cohort study will study the exposure to intraoperative hypotension and the occurrence of sepsis after the ERCP procedures.', 'armGroupLabels': ['intraoperative hypotension']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Aldakahlia', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Mansoura Univesity Faculty of Medicine', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Moataz M Emara, MD, EDAIC', 'role': 'CONTACT', 'email': 'mm.emara@mans.edu.eg', 'phone': '+201064048848'}, {'name': 'Ahmed Ali El-Din, Msc', 'role': 'CONTACT', 'phone': '0201288045390'}], 'overallOfficials': [{'name': 'Moataz M Emara, MD, EDAIC', 'role': 'STUDY_CHAIR', 'affiliation': 'Mansoura University Hospital'}]}, 'ipdSharingStatementModule': {'timeFrame': 'within 2 years after publication', 'ipdSharing': 'YES', 'description': 'The anonymized patient data will be available with the principal investigator and can be shared on reasonable request after approval of the IRB.', 'accessCriteria': 'with contact with the principal investigator with reasonable request and approval of the local IRB.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}