Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-25 @ 7:11 PM
Study NCT ID:
NCT07206732
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
IVC Ultrasound Versus Central Venous Pressure for Early Detection of Hypovolemia in Shock Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012769', 'term': 'Shock'}, {'id': 'D020896', 'term': 'Hypovolemia'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-16', 'studyFirstSubmitDate': '2025-09-26', 'studyFirstSubmitQcDate': '2025-09-26', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation Between IVC Collapsibility Index and Central Venous Pressure', 'timeFrame': 'IVC assessment will be performed at presentation and 1 hour post-resuscitation, while CVP will be monitored continuously during the first 6 hours after ED admission.', 'description': 'The primary outcome is to assess the diagnostic agreement between ultrasound-guided inferior vena cava (IVC) collapsibility index and central venous pressure (CVP) values in detecting hypovolemia among shock patients in the emergency department. Measurements will be collected at two time points: during early presentation and after initial fluid resuscitation. The outcome will be evaluated by analyzing correlation coefficients, sensitivity, and specificity of IVC measurements compared with CVP'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Shock', 'Hypovolemia', 'Emergency department', 'Central venous pressure', 'Fliud resuscitation', 'Ultrasound guided IVC'], 'conditions': ['Shock', 'Hypovolemia', 'Circulatory Failure']}, 'descriptionModule': {'briefSummary': 'This study aims to compare ultrasound-guided inferior vena cava (IVC) assessment with central venous pressure (CVP) monitoring for the detection of hypovolemia in shock patients in the emergency department. The primary objective is to evaluate the diagnostic accuracy and clinical utility of IVC collapsibility index compared to CVP values in both early and post-resuscitation phases. The study will prospectively enroll shock patients, collect demographic and clinical data, and analyze the correlation between IVC and CVP measurements to determine their role in guiding fluid resuscitation and hemodynamic management.', 'detailedDescription': 'Hypovolemia is a major contributor to morbidity and mortality among patients presenting with shock in the emergency department. Early recognition and accurate assessment of intravascular volume status are essential for effective resuscitation. Central venous pressure (CVP) monitoring has traditionally been used but is invasive and may not always accurately reflect volume status. Ultrasound-guided inferior vena cava (IVC) assessment offers a non-invasive alternative, with the IVC collapsibility index shown to correlate with volume responsiveness. This prospective observational study will enroll patients diagnosed with shock and compare IVC measurements with CVP values during both early presentation and post-resuscitation phases. The findings are expected to provide evidence on the diagnostic agreement between IVC ultrasound and CVP monitoring, potentially supporting the use of IVC ultrasound as a rapid, reliable, and less invasive tool for guiding fluid therapy in emergency settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include adult patients aged 18-65 years presenting with shock to the emergency department and requiring volume status assessment through both IVC ultrasound and central venous pressure monitoring.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1- Adult patients aged ≥18 years. 2.Both male and female patients will be included in the study. 3. Presentation to the Emergency Department with clinical evidence of shock, defined by: Hypotension (systolic blood pressure \\<90 mmHg or mean arterial pressure \\<65 mmHg).\n\nEvidence of tissue hypoperfusion (e.g., altered mental status, cold extremities, or oliguria).\n\nElevated serum lactate (\\>2 mmol/L). 4. Shock attributed to hypovolemic, septic, or hemorrhagic etiologies. 5. Patients requiring fluid resuscitation and hemodynamic monitoring.\n\nExclusion Criteria:\n\n1 - Patients younger than 18 years. 2. Pregnancy. 3.Cardiogenic or obstructive shock (e.g., cardiac tamponade, massive pulmonary embolism, or tension pneumothorax).\n\n4.Known inferior vena cava (IVC) anomalies (e.g., congenital absence, thrombosis).\n\n5\\. Increased intra-abdominal pressure or severe ascites. 6. Morbid obesity (BMI ≥40 kg/m²) or any condition interfering with adequate IVC ultrasound visualization.\n\n7\\. Prior central venous catheterization performed before Emergency Department arrival.\n\n8\\. Congestive heart failure (CHF) with left ventricular ejection fraction (LVEF \\<40%) or pulmonary hypertension.\n\n9\\. Refusal of the patient or legal guardian to participate in the study.'}, 'identificationModule': {'nctId': 'NCT07206732', 'briefTitle': 'IVC Ultrasound Versus Central Venous Pressure for Early Detection of Hypovolemia in Shock Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Ultrasound-Guided Inferior Vena Cava Assessment Versus Central Venous Pressure Monitoring in Early and Post-Resuscitation Detection of Hypovolemia Among Shocked Patients in the Emergency Department', 'orgStudyIdInfo': {'id': 'IVC-CVP-ShockED-2025'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ultrasound-Guided Inferior Vena Cava Assessment', 'type': 'DEVICE', 'description': 'This intervention involves bedside ultrasound measurement of the inferior vena cava (IVC) diameter and calculation of the IVC collapsibility/distensibility index. Assessments will be performed both at initial presentation and after fluid resuscitation in shock patients. The procedure is non-invasive, rapid, and performed according to standardized emergency ultrasound protocols, distinguishing it from invasive monitoring methods.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'state': 'Sahel Selim', 'country': 'Egypt', 'contacts': [{'name': 'Mahmoud Ahmed Mohamed Abd Elgwad, M.B.B.Ch', 'role': 'CONTACT', 'email': 'mahmoudataay12@gmail.com', 'phone': '+01280752523'}], 'facility': 'Emeregency medicine department ,Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Mahmoud Ahmed Mohamed Abd Elgwad, M.B.B.Ch', 'role': 'CONTACT', 'email': 'mahmoudataay12@gmail.com', 'phone': '+01280752523'}], 'overallOfficials': [{'name': 'Alaa M Attia, Professor of Anathesia and ICU', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assit University'}, {'name': 'Ahmed M Mandor, Consultant of Anathesia ICU', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}, {'name': 'Walaa M Adel, Lecture of emergency medicine', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seuz canal University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared because the study is conducted as part of an academic thesis project. Data are limited to internal use within the research team and protected by institutional and ethical regulations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator at Emergency Medicine department Assiut University', 'investigatorFullName': 'Mahmoud Ahmed Mohamed Abd Elgwad', 'investigatorAffiliation': 'Assiut University'}}}}