Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-28 @ 10:01 AM
Study NCT ID:
NCT05096559
Status:
UNKNOWN
Last Update Posted:
2021-10-27
First Post:
2021-10-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Sublingual Microcirculation in Burn During Resuscitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-15', 'studyFirstSubmitDate': '2021-10-15', 'studyFirstSubmitQcDate': '2021-10-15', 'lastUpdatePostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '• Lactate level', 'timeFrame': '24 hours', 'description': 'mmol/L'}], 'secondaryOutcomes': [{'measure': 'total vessel density', 'timeFrame': '24 hours', 'description': 'mm/mm2'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Burn Shock']}, 'descriptionModule': {'briefSummary': 'The adequacy of fluid resuscitation will be monitored in burn patients using microcirculation.\n\nMicrocirculation camera will be placed on the base of the tongue and at different four quadrants. • Microcirculation parameters at baseline and after 8h , 16h and 24h of fluid resuscitation will be recorded. Fluid resuscitation with lactated ringer according to Parkland formula (4 ml/kg/%TBSA) 50% given during the first 8 hours, with the remainder given during the following 16 hours, will be initiated to maintain a urinary output of 0.5ml/kg/hr.Norepinephrine infusion will be started in case of circulatory failure at a rate of 0.02mic/kg/min to maintain MAP of 65-70mmHg.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with burns greater than 20% TBSA admitted to ICU within the 1st 6 hours post-burn', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age more than 18 years old\n* Burn \\>20% TBSA\n* Patients with burn admitted within the 1st 6 hours\n\nExclusion Criteria:\n\n* Age \\< 18 years old.\n* Pregnant patients.\n* Patients with severe renal insufficiency.\n* Patients shocked due to other causes as sepsis, hypovolaemia or cardiogenic shock\n* Patients with airway edema that preclude the measurement of sublingual microcirculation'}, 'identificationModule': {'nctId': 'NCT05096559', 'briefTitle': 'Evaluation of Sublingual Microcirculation in Burn During Resuscitation', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'The Evaluation of Sublingual Microcirculation To Guide Fluid Resuscitation In Patients With Burn: Prospective Observational Study', 'orgStudyIdInfo': {'id': 'N-111-2017'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Microcirculation cytocam', 'type': 'DEVICE', 'description': 'Visualization of tongue microcirculation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11562', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Shymaa Fathy', 'role': 'CONTACT', 'email': 'angel6122003@yahoo.com', 'phone': '01000455897'}], 'facility': 'Kasr Al Ainy hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Shymaa Fathy, MD', 'role': 'CONTACT', 'email': 'angel6122003@yahoo.com', 'phone': '+201000455897', 'phoneExt': '002'}, {'name': 'Shymaa Mahmoud, MMSc', 'role': 'CONTACT', 'email': 'dr_shoshomahmoud2003@yahoo.com', 'phone': '0106469416', 'phoneExt': '002'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of anesthesia and SICU', 'investigatorFullName': 'Shymaa Fathy', 'investigatorAffiliation': 'Cairo University'}}}}