Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-31 @ 4:07 AM
Study NCT ID:
NCT06311903
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Norepinephrine in Preperiod of Hypotensive Resuscitation in Hemorrhagic Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012771', 'term': 'Shock, Hemorrhagic'}], 'ancestors': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009638', 'term': 'Norepinephrine'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-09', 'studyFirstSubmitDate': '2024-03-09', 'studyFirstSubmitQcDate': '2024-03-09', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '24 hours mortality', 'timeFrame': '24 hours after intervention', 'description': '24 hours mortality will be measured.'}], 'secondaryOutcomes': [{'measure': '28 day mortality', 'timeFrame': '28 days after intervention', 'description': '28 day mortality will be measured.'}, {'measure': 'Incidence of acute kidney injury', 'timeFrame': '24 hours after intervention', 'description': 'Incidence of acute kidney injury will be measured within 24 hours.'}, {'measure': 'Length of hospital stay', 'timeFrame': '28 days after intervention', 'description': 'Length of hospital stay will be measured from admission till hospital discharge.'}, {'measure': 'Length of intensive care unit stay', 'timeFrame': '28 days after intervention', 'description': 'Length of intensive care unit (ICU) stay will be measured from admission till intensive care discharge.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Norepinephrine', 'Hemorrhagic Shock', 'Hypotensive Resuscitation']}, 'descriptionModule': {'briefSummary': 'The aim of this work was to investigate the effects of low dose of norepinephrine in preperiod of hypotensive resuscitation in hemorrhagic shock.', 'detailedDescription': 'Hemorrhagic shock is one of the leading causes of death following trauma. New fluid resuscitation concepts, including hypotensive, hypothermic, and delayed resuscitation for uncontrolled hemorrhagic shock, have been put forward and obtained a good effect both in clinical and laboratory parameters. The 2019 European guideline on the management of major bleeding and coagulopathy following trauma recommends the use of norepinephrine (NE) for maintaining target arterial blood pressure in patients with life-threatening hypotension. NE has potent α-adrenergic receptor activation activity, which can stimulate α-1 adrenergic receptors on peripheral vascular smooth muscles. High-dose NE may result in excessive arteriolar vasoconstriction which subsequently leads to the disorder of microcirculation and tissue hypoxia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old.\n* Both sexes.\n* Patients with hemorrhagic shock\n\nExclusion Criteria:\n\n* Patients with cardiac arrest at admission.\n* Severe brain.\n* Spinal injury (because of different target blood pressures).\n* Death due to hemostatic failure within 6 h of admission.\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT06311903', 'briefTitle': 'Norepinephrine in Preperiod of Hypotensive Resuscitation in Hemorrhagic Shock', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Is Low Dose Norepinephrine Effective in Preperiod of Hypotensive Resuscitation in Hemorrhagic Shock?', 'orgStudyIdInfo': {'id': '36264PR430/11/23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I', 'description': 'Patients were received resuscitative fluid \\[administered at beginning with the arrival of the patient in the emergency department (mean blood pressure \\>70 mmHg)\\] followed by low dose of norepinephrine (NE) (0.05-0.2 μg/kg/min).', 'interventionNames': ['Drug: Low dose of Norepinephrine (NE)']}, {'type': 'EXPERIMENTAL', 'label': 'Group II', 'description': 'patients were received resuscitative fluid. If there were no response to treatment to resuscitative fluid, they received norepinephrine (NE) gradually till reach high dose (≥0.3 μg/kg/min).', 'interventionNames': ['Drug: High dose of Norepinephrine (NE)']}], 'interventions': [{'name': 'Low dose of Norepinephrine (NE)', 'type': 'DRUG', 'description': 'Patients were received resuscitative fluid \\[administered at beginning with the arrival of the patient in the emergency department (mean blood pressure \\>70 mmHg)\\] followed by low dose of NE (0.05-0.2 μg/kg/min).', 'armGroupLabels': ['Group I']}, {'name': 'High dose of Norepinephrine (NE)', 'type': 'DRUG', 'description': 'Patients were received resuscitative fluid. If there were no response to treatment to resuscitative fluid, they received NE gradually till reach high dose (≥0.3 μg/kg/min).', 'armGroupLabels': ['Group II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El-Gharbia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Rabab M Mohamed, MD', 'role': 'CONTACT', 'email': 'rabmoh_30@outlook.com', 'phone': '00201069122935'}, {'name': 'Atia G Anwar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ahmed A Eid, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Rabab M Mohamed, MD', 'role': 'CONTACT', 'email': 'rabmoh_30@outlook.com', 'phone': '00201069122935'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.', 'investigatorFullName': 'Rabab Mohamed Mohamed Mohamed', 'investigatorAffiliation': 'Tanta University'}}}}