Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:55 AM
Study NCT ID:
NCT07321405
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-07
First Post:
2025-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Cardiac Output and Stroke Volume in Septic Shock Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'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'}, {'id': 'D012769', 'term': 'Shock'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004452', 'term': 'Echocardiography'}], 'ancestors': [{'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-12-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-28', 'studyFirstSubmitDate': '2025-11-24', 'studyFirstSubmitQcDate': '2025-12-28', 'lastUpdatePostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to compare the accuracy and reliability of electrical cardiometry versus transthoracic echocardiography in measuring cardiac output in patients with septic shock.', 'timeFrame': '2026-2028', 'description': 'to compare the accuracy and reliability of electrical cardiometry versus transthoracic echocardiography in measuring cardiac output in patients with septic shock.'}, {'measure': 'cardiac output and stroke volume in septic shock patients', 'timeFrame': 'baseline', 'description': 'comparison between accuracy and reliability in assessment of cardiac out put and stroke volume using echocardiogram vs electrical cardiometer'}, {'measure': 'to compare the accuracy and reliability of electrical cardiometry versus transthoracic echocardiography in measuring stroke volume in patients with septic shock.', 'timeFrame': '2026-2028', 'description': 'to compare the accuracy and reliability of electrical cardiometry versus transthoracic echocardiography in measuring stroke volume in patients with septic shock.'}]}, 'conditionsModule': {'conditions': ['Septic Shock']}, 'referencesModule': {'references': [{'pmid': '40082773', 'type': 'BACKGROUND', 'citation': 'Song W, Guo J, Cao D, Jiang J, Yang T, Ma X, Yuan H, Wu J, Guan X, Si X. Comparison of noninvasive electrical cardiometry and transpulmonary thermodilution for cardiac output measurement in critically ill patients: a prospective observational study. BMC Anesthesiol. 2025 Mar 13;25(1):123. doi: 10.1186/s12871-025-03005-1.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/40082773/', 'label': 'https://pubmed.ncbi.nlm.nih.gov/40082773/'}]}, 'descriptionModule': {'briefSummary': 'The aim of this research is to compare the accuracy and reliability of electrical cardiometry versus transthoracic echocardiography in measuring cardiac output and stroke volume in patients with septic shock, to evaluate the potential of EC as a non-invasive alternative for hemodynamic monitoring.', 'detailedDescription': "Sepsis is a life-threatening condition caused by a dysregulated immune response to infection, leading to organ dysfunction. It remains a leading global cause of morbidity and mortality, often progressing rapidly to septic shock and multi-organ failure if not promptly diagnosed and treated.\n\nThe complex pathophysiology involves systemic inflammation, endothelial damage, and impaired tissue perfusion, making early recognition and hemodynamic stabilization vital for survival. Accurate monitoring of cardiac function plays a key role in managing septic patients.\n\nCardiac output (CO) and stroke volume (SV) are key hemodynamic parameters guiding therapy in critically ill patients, particularly those with pneumonia and septic shock, who experience severe circulatory and respiratory dysfunction contributing to their high mortality.\n\nTransthoracic echocardiography (TTE) is the gold standard for non-invasive bedside assessment of CO and SV, providing precise evaluation of cardiac structure and flow. However, TTE requires operator expertise, can be time-consuming, and may be limited by patient-specific factors.\n\nElectrical cardiometry (EC) is an emerging non-invasive bio-impedance technique offering continuous monitoring with easier application and less operator dependency. Despite its advantages, EC's accuracy and reliability in critically ill septic patients require further validation.\n\nCurrently, hemodynamic monitoring mainly relies on clinical assessment combined with intermittent TTE, with invasive methods reserved for selective cases; EC holds potential as a simpler, safer alternative warranting further investigation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients were aged more than 18 years diagnosed with septic shock following the surviving sepsis campaign\n\n\\-', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: patients aged more than 18 years must be diagnosed with septic shock following the surviving sepsis campaign\n\n\\-\n\nExclusion Criteria:\n\n* patients aged less than 18 years pregnant women cases suffering cardiac diseases (heart failure, arrhythmia, moderate, and severe valvular disease) patients with poor quality echocardiographic images and measurements'}, 'identificationModule': {'nctId': 'NCT07321405', 'briefTitle': 'Assessment of Cardiac Output and Stroke Volume in Septic Shock Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Non Invasive Hemodynamic Assessment of Cardiac Output and Stroke Volume in Septic Shock Patients', 'orgStudyIdInfo': {'id': 'COP and SV in septic shock'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'septic shock patients', 'description': 'echocardiography and electrical cardiometry will be applied to these patients', 'interventionNames': ['Device: echocardiogram', 'Device: Electrical cardiometry']}], 'interventions': [{'name': 'echocardiogram', 'type': 'DEVICE', 'description': 'Transthoracic echocardiography (TTE) is the gold standard for non-invasive bedside assessment of CO and SV, providing precise evaluation of cardiac structure and flow. However, TTE requires operator expertise, can be time-consuming, and may be limited by patient-specific factors.', 'armGroupLabels': ['septic shock patients']}, {'name': 'Electrical cardiometry', 'type': 'DEVICE', 'description': "Electrical cardiometry (EC) is an emerging non-invasive bio-impedance technique offering continuous monitoring with easier application and less operator dependency. Despite its advantages, EC's accuracy and reliability in critically ill septic patients require further validation.", 'armGroupLabels': ['septic shock patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71511', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut University Hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Osman khalaf, bachelor', 'role': 'CONTACT', 'email': 'om62326232@gmail.com', 'phone': '01098360564'}, {'name': 'osman khalaf, resident', 'role': 'CONTACT', 'phone': '01098360564'}], 'overallOfficials': [{'name': 'ahmed obeid allah, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}, {'name': 'alaa abd elbadee, lecturer', 'role': 'STUDY_CHAIR', 'affiliation': 'Assiut University'}, {'name': 'mostafa hosney, lecturer', 'role': 'STUDY_CHAIR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident physician', 'investigatorFullName': 'Osman Mohamed Osman Khalaf', 'investigatorAffiliation': 'Assiut University'}}}}