Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-27 @ 8:21 AM
Study NCT ID:
NCT05369559
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2022-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mini Bolus for Fluid Challenge Responsiveness in the Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The fluid challenge is given intravenously via a specific venous line.\n\nPatients are assigned in a random chronological order to:\n\n* receive a "mini-bolus ":50 ml of crystalloid solution, regularly infused over 30 seconds\n* and passive leg raising.\n\nPassive leg raising technique: Initially, the patient is placed semi-recumbent with the head of the bed at 45°. After recording baseline measurement, the head of the bed is lowered and the legs are elevated to 45° for 2 minutes.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-05-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-04', 'studyFirstSubmitDate': '2022-03-14', 'studyFirstSubmitQcDate': '2022-05-05', 'lastUpdatePostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of the cardiac flow with the Estimate Continuous CO escco and SVescco (EsCCO) to predict the fluid responsiveness .', 'timeFrame': 'at 3 minutes following fluid load in the day of admission', 'description': 'Predicting fluid responsiveness in spontaneously breathing patients with hemodynamic instability.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fluid Therapy']}, 'descriptionModule': {'briefSummary': 'Intravascular volume expansion is a common intervention in critically ill patients with acute circulatory failure.we test the hypothesis that a mini-bolus fluid challenge, of either 50 ml , can predict fluid responsiveness in spontaneously breathing patients with hemodynamic instability.', 'detailedDescription': 'Background:\n\nIntravascular volume expansion is a common intervention in critically ill patients with acute circulatory failure. Nevertheless, approximately 50% of critically ill patients will not benefit from an intravascular volume expansion, since they are in the horizontal portion of the Frank-Starling curve.\n\nThus, an accurate assessment of fluid responsiveness prior to volume expansion is mandatory to avoid fluid overload, which has been associated with increased morbidity and mortality in critically ill patients.\n\nFluid challenge, which consists of administering fluid to assess volume responsiveness, is widely performed. However, repeated fluid challenges, several times a day, can be harmful Indeed, if cardiopulmonary function cannot compensate for the increase in preload, fluid loading can compromise micro-vascular perfusion and oxygen delivery or aggravate peripheral and pulmonary oedema.\n\nFor many years, spontaneous breathing was considered a major limitation to assess fluid responsiveness in critically ill patients .\n\nIn this study, the investigator test the hypothesis that a mini-bolus fluid challenge of 50 ml can predict fluid responsiveness in spontaneously breathing patients with hemodynamic instability.\n\nPassive leg raising technique: Initially, the patient is placed semi-recumbent with the head of the bed at 45°. After recording baseline measurement, the head of the bed is lowered and the legs are elevated to 45° for 2 minutes.\n\nFluid challenge responsiveness:\n\nFluid responsiveness is defined as an increase in the cardiac output measured using FloTrac-Vigileo monitor (∆CO-PLR \\> 10%) after the PLR, separating the studied population into responders and non-responders.\n\nMeasurements:\n\nPatients characteristics, including age and sex, are recorded at admission. The aetiology of acute circulatory failure, the inotropic and/or vasopressor support (epinephrine, norepinephrine and dobutamine) and the APACHE II score are recorded.\n\nThe following hemodynamic variables are recorded: heart rate (beats per minute), systolic blood pressure (mmHg), diastolic blood pressure (mmHg), and mean arterial blood pressure (mmHg). These variables are collected at baseline (T0), immediately before mini-bolus infusion (T50b, T50a), and immediately before the PLR manoeuvre (TPLRb and TPLRa).\n\nCardiac output (CO) and stroke volume (SV) are measured using both an EsCCO monitor (COescco and SVescco) and a FloTrac transducer connected to a Vigileo monitor (COflotrac and SVflotrac). CO and SV are measured at baseline, before and after each mini-bolus infusion, and before and after passive leg raising. They are recorded at the moment when they plateau. The hemodynamic variables cited above are also recorded at that time.\n\nChanges -induced by the mini-boluses and by the PLR- in all parameters were measured; these were referred to as ∆\\[parameter\\]50 and ∆\\[parameter\\]PLR.\n\nIf patients were treated with norepinephrine, the dose remained unchanged from before volume expansion until all hemodynamic measurements were complete.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with spontaneous breathing\n* Patients in whom a fluid challenge is indicated because they present acute circulatory failure (which is defined as systolic blood pressure less than 90 mmHg or the need for vasopressors (norepinephrine more than 0.1 µg/kg/min) to maintain a systolic blood pressure more than 90 mmHg (14), and at least one sign of inadequate tissue perfusion:\n\n * urine output of below 0.5ml/kg per hour over 1 hour\n * tachycardia (heart rate of greater than 100 beats per minute)\n * mottled skin.\n * lactate \\> 2 mmol/l\n\nExclusion Criteria:\n\n* Cardiac arrest\n* Acute respiratory distress syndrome\n* Coma Glasgow Scale \\< 14\n* Age of less than 18 years\n* Moribund patients\n* Pregnant patients\n* impossibility to perform passive leg raising (PLR) (trauma patients, lower extremity amputees, and prone patients)\n* Patients with cardiac arrhythmias\n* Patients with cardiogenic pulmonary oedema'}, 'identificationModule': {'nctId': 'NCT05369559', 'acronym': 'MIBORED', 'briefTitle': 'Mini Bolus for Fluid Challenge Responsiveness in the Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'University of Monastir'}, 'officialTitle': 'Mini Bolus for Fluid Challenge Responsiveness in the Emergency Department', 'orgStudyIdInfo': {'id': 'TN2020-NA T -INS-399'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mini Bolus 50', 'description': 'receiving a "mini-bolus A":50 ml of crystalloid solution, regularly infused over 30 seconds', 'interventionNames': ['Diagnostic Test: passive leg rising test']}, {'type': 'OTHER', 'label': 'PLR', 'description': 'Passive leg raising technique: Initially, the patient is placed semi-recumbent with the head of the bed at 45°. After recording baseline measurement, the head of the bed is lowered and the legs are elevated to 45° for 2 minutes', 'interventionNames': ['Combination Product: Mini bolus 50']}], 'interventions': [{'name': 'Mini bolus 50', 'type': 'COMBINATION_PRODUCT', 'description': 'receiving a "mini-bolus A":50 ml of crystalloid solution, regularly infused over 30 seconds', 'armGroupLabels': ['PLR']}, {'name': 'passive leg rising test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Passive leg raising technique: Initially, the patient is placed semi-recumbent with the head of the bed at 45°. After recording baseline measurement, the head of the bed is lowered and the legs are elevated to 45° for 2 minutes', 'armGroupLabels': ['Mini Bolus 50']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Monastir', 'status': 'RECRUITING', 'country': 'Tunisia', 'contacts': [{'name': 'Semir Nouira, professor', 'role': 'CONTACT', 'email': 'semir.nouira@rns.tn', 'phone': '73 106 085', 'phoneExt': '216'}, {'name': 'kouraichi cyrine, MD', 'role': 'CONTACT', 'email': 'cyrinekouraichi@hotmail.com', 'phone': '55598213', 'phoneExt': '216'}, {'name': 'semir nouira, professor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Khaoula Bel Haj Ali, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Emergency Departement', 'geoPoint': {'lat': 35.77799, 'lon': 10.82617}}, {'city': 'Monastir', 'status': 'RECRUITING', 'country': 'Tunisia', 'contacts': [{'name': 'Semir Nouira, head chief', 'role': 'CONTACT', 'email': 'semir.nouira@rns.tn', 'phone': '+21673106046'}, {'name': 'Semir Nouira', 'role': 'CONTACT', 'email': 'semir.nouira.urg@gmail.com', 'phone': '+21673106000'}], 'facility': 'Emergency department', 'geoPoint': {'lat': 35.77799, 'lon': 10.82617}}], 'centralContacts': [{'name': 'Semir Nouira, Prof', 'role': 'CONTACT', 'email': 'semir.nouira.urg@gmail.com', 'phone': '+21673106046'}, {'name': 'Khaoula Bel Haj Ali, MD', 'role': 'CONTACT', 'email': 'belhajalikhaoula@yahoo.fr', 'phone': '99792724'}], 'overallOfficials': [{'name': 'Semir Nouira, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Fattouma Bourguiba Monastir , Emergency Department .'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Monastir', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head chief, Emmergency Department ,University Hospital of Monastir', 'investigatorFullName': 'Pr. Semir Nouira', 'investigatorAffiliation': 'University of Monastir'}}}}