Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-01-05 @ 12:28 PM
Study NCT ID:
NCT02631356
Status:
UNKNOWN
Last Update Posted:
2015-12-17
First Post:
2015-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Succinylated Gelatin on the Blood Viscosity and Oxygen Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077325', 'term': "Ringer's Lactate"}, {'id': 'C060085', 'term': 'succinylated gelatin'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'lastUpdateSubmitDate': '2015-12-16', 'studyFirstSubmitDate': '2015-11-24', 'studyFirstSubmitQcDate': '2015-12-11', 'lastUpdatePostDateStruct': {'date': '2015-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The patient's arterial blood viscosity (mpa.s) as tested by viscometer", 'timeFrame': 'up to 5 months (after the infusion of succinylated gelatin )'}], 'secondaryOutcomes': [{'measure': "The patient's oxygen delivery index (DO2I) as calculated by Vigileo", 'timeFrame': 'up to 5 months (after the infusion of succinylated gelatin )'}]}, 'conditionsModule': {'conditions': ['Blood Viscosity']}, 'descriptionModule': {'briefSummary': 'The study is to investigate the effect of succinylated gelatin on the blood viscosity and oxygen delivery in patients during surgeries, so as to have a better understanding of the safety in the use of succinylated gelatin for surgical patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between the ages of 18 years and 60 years\n* ASA physical status I and II\n* surgical procedures requiring general anesthesia with continuous CVP and arterial pressure monitoring\n\nExclusion Criteria:\n\n* Patients younger than 16 y or older than 60 y\n* Body Mass Index (BMI) \\<18 or \\>30\n* Allergy to any of the drugs used\n* Severe cardiovascular dysfunction\n* Patient refusal'}, 'identificationModule': {'nctId': 'NCT02631356', 'briefTitle': 'The Effect of Succinylated Gelatin on the Blood Viscosity and Oxygen Delivery', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital, Sun Yat-Sen University'}, 'orgStudyIdInfo': {'id': '2015[22]'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': "Ringer's lactate solution", 'description': "Infusion of Ringer's lactate solution (10ml/kg) in the control group", 'interventionNames': ["Drug: Ringer's lactate solution"]}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Succinylated gelatin', 'description': 'Infusion of Succinylated gelatin (10ml/kg) in the test group', 'interventionNames': ['Drug: Succinylated gelatin']}], 'interventions': [{'name': "Ringer's lactate solution", 'type': 'DRUG', 'armGroupLabels': ["Ringer's lactate solution"]}, {'name': 'Succinylated gelatin', 'type': 'DRUG', 'armGroupLabels': ['Succinylated gelatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xia Feng, MD. Ph.D.', 'role': 'CONTACT', 'email': 'fengxia@mail.sysu.edu.cn', 'phone': '13688877856'}], 'facility': 'The First Affiliated Hospital of Sun Yat-Sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Xia Feng, MD. Ph.D.', 'role': 'CONTACT', 'email': 'fengxia@mail.sysu.edu.cn', 'phone': '13688877856'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Feng Xia', 'investigatorAffiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}}}}