Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 9:15 AM
Study NCT ID:
NCT07411469
Status:
RECRUITING
Last Update Posted:
2026-02-13
First Post:
2026-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Using Cardiometry and IVC Collapsibility
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-05-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-08', 'studyFirstSubmitDate': '2026-01-30', 'studyFirstSubmitQcDate': '2026-02-08', 'lastUpdatePostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Septic Shock Evaluation', 'timeFrame': 'Two Hours', 'description': 'Assessment of the participants which suffering from Septic Shock by using Inferior Vena Cava Collapsibility and Electrical Cardiometry for assisting the Fluid Responsiveness'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Septic Shock']}, 'descriptionModule': {'briefSummary': 'Sepsis is a life-threatening condition caused by a dysregulated host response to infection, leading to organ dysfunction. Septic shock, a severe form of sepsis, is characterized by persistent hypotension and cellular/metabolic abnormalities despite adequate fluid resuscitation. It is associated with high mortality rates globally, necessitating timely diagnosis and treatment. Fluid resuscitation and vasopressor use are cornerstones of management, but they must be tailored to the individual to prevent complications such as fluid overload.', 'detailedDescription': "Predicting fluid responsiveness in critically ill patients is crucial to optimizing fluid therapy. Traditional static measures like central venous pressure (CVP) are unreliable, while dynamic indices such as stroke volume variation (SVV) and pulse pressure variation (PPV) are considered more accurate but limited to specific conditions. Novel, non-invasive tools for predicting fluid responsiveness are particularly valuable in heterogeneous patient populations, including those with spontaneous breathing or arrhythmias.\n\nNon-invasive cardiometry, utilizing advanced hemodynamic monitoring technologies, offers another method to assess fluid responsiveness. By measuring parameters such as stroke volume and cardiac output, non-invasive cardiometry provides real-time insights into a patient's hemodynamic status without the need for invasive procedures. This approach has the potential to guide fluid management effectively, especially in critically ill patients where invasive monitoring may pose additional risks.\n\nElectrical cardiometry (EC) was introduced as a new bio impedance method with the new algorithm for processing the impedance signal to overcome the limitations associated with bio impedance which are used to measure and calculate hemodynamic parameters as cardiac output, cardiac index, SV and systemic vascular resistance index."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study protocol approval prior to implementation of the research will be obtained from Faculty of Medicine, Menoufia University Research Ethics Committee. Parents were informed about the study purpose and its consequences, confirming confidentiality of data. A signed informed consent was a pre-requisite for the study.\n\nType of study:\n\nProspective study\n\nSite of study:\n\nThis study will be conducted at the Intensive Care Unit, Faculty of Medicine, Menoufia university Hospital.\n\nThe study population:\n\nThe study will include (60) septic Shock patients who admitted to Intensive Care Unit.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients Diagnosed with Hypotensive Sepsis: Patients must meet the clinical criteria for sepsis according to the Sepsis-3 definitions, including evidence of infection and hypotension despite adequate fluid resuscitation. Hypotension is defined as systolic blood pressure \\<90 mmHg or mean arterial pressure (MAP) \\<65 mmHg.\n* BMI ≥18.5 and ≤40 kg/m²: Patients will be included regardless of BMI, as long as it falls within the normal to overweight/obese range. Extremes of BMI (e.g., \\<18.5 or \\>40) may be excluded due to the potential influence on peripheral perfusion measurements.\n* American Society of Anesthesiologists (ASA) Physical Status Classification as:\n\nASA Score I-III: Patients with an ASA physical status score of I (healthy patients), II (mild systemic disease), or III (severe systemic disease) will be included. Patients with ASA IV or V (those with severe systemic disease that is a constant threat to life) will be excluded due to potential confounding factors.\n\nExclusion Criteria:\n\n\\- Cardiac Conditions: Significant valvular heart diseases, such as severe mitral or aortic regurgitation, which can affect hemodynamic assessments.\n\nPresence of major cardiac arrhythmias, including atrial fibrillation or frequent ectopic beats, as these can interfere with accurate measurement of fluid responsiveness.\n\n\\- Renal Considerations: Patients undergoing renal replacement therapy or those with end-stage renal disease, as fluid balance and responsiveness may be altered.\n\n* Pregnancy Hemodynamic changes during pregnancy (e.g., increased cardiac output and altered vascular resistance) differ significantly from septic shock.\n* Patients with a body mass index (BMI) greater than 40 kg/m² Obesity can affect the accuracy of non-invasive monitoring techniques with poor window.'}, 'identificationModule': {'nctId': 'NCT07411469', 'briefTitle': 'Comparison Between Using Cardiometry and IVC Collapsibility', 'organization': {'class': 'OTHER', 'fullName': 'Menoufia University'}, 'officialTitle': 'Comparison Between Using Cardiometry and IVC Collapsibility in Predicting Fluid Responsiveness in Hypovolemic Sepsis Patients', 'orgStudyIdInfo': {'id': 'Cardiometry and IVC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Electrical Cardiometry Monitoring', 'description': 'Non-invasive assessment of stroke volume and cardiac output using electrical cardiometry at baseline and after fluid challenge.', 'interventionNames': ['Procedure: Cardiometry']}, {'label': 'Inferior Vena Cava Collapsibility Assessment Group', 'description': 'Thirty patients with septic shock will undergo bedside ultrasound assessment of the inferior vena cava to measure the collapsibility index for evaluation of fluid responsiveness. Measurements will be performed as part of routine clinical monitoring without any alteration to standard clinical management.', 'interventionNames': ['Procedure: Cardiometry']}], 'interventions': [{'name': 'Cardiometry', 'type': 'PROCEDURE', 'otherNames': ['Inferior Vena Cava Ultrasound Assessment'], 'description': 'Bedside ultrasound measurement of inferior vena cava diameters during the respiratory cycle to calculate the collapsibility index at baseline and after fluid challenge', 'armGroupLabels': ['Electrical Cardiometry Monitoring', 'Inferior Vena Cava Collapsibility Assessment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23511', 'city': 'Shibīn al Kawm', 'state': 'Menoufia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Noha Abdallah Afify, Professor', 'role': 'CONTACT', 'email': 'nohaafify2014@gmail.com', 'phone': '+201069113014'}, {'name': 'Marwa Abdelmonem Abdallah, Lecturer', 'role': 'CONTACT', 'email': 'marwamarwamarwa88@yahoo.com', 'phone': '+201092646406'}], 'facility': 'Menoufia University Hospital', 'geoPoint': {'lat': 30.55258, 'lon': 31.00904}}], 'centralContacts': [{'name': 'Ahmed Mohamed Fared, MSc', 'role': 'CONTACT', 'email': 'ahmedm.fared9@gmail.com', 'phone': '+201005305140'}, {'name': 'Mohamed Fathy Abdelaziz, Lecturer', 'role': 'CONTACT', 'email': 'Dr_mohamed_fathy251@yahoo.com', 'phone': '+201002209632'}], 'overallOfficials': [{'name': 'Noha Abdallah Afify, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Anaesthesia, Intensive Care and Pain Management, Faculty of Medicine, Menoufia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Menoufia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident at Anaesthesia, Intensive Care and Pain Management Department', 'investigatorFullName': 'Ahmed Fared', 'investigatorAffiliation': 'Menoufia University'}}}}