Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-02-20 @ 10:45 PM
Study NCT ID:
NCT01225159
Status:
TERMINATED
Last Update Posted:
2015-12-18
First Post:
2010-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tight Glycaemic Control During Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D007003', 'term': 'Hypoglycemia'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rpanthi@medicine.psu.ac.th', 'phone': '+66 74 45 1651', 'title': 'Dr.Panthila Rujirojindakul, Staff', 'organization': 'Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla 90110, Thailand'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '30 days postoperative', 'eventGroups': [{'id': 'EG000', 'title': 'Tight Glycaemic Control (TGC)', 'description': 'Allocated to control group (n = 100)\n\n* Received allocated intervention (n = 99)\n* Did not receive allocated intervention: change operation (n = 1)', 'otherNumAtRisk': 99, 'otherNumAffected': 17, 'seriousNumAtRisk': 99, 'seriousNumAffected': 23}, {'id': 'EG001', 'title': 'Conventional Glycaemic Control (Control)', 'description': 'Allocated to intensive group (n = 100)\n\n• Received allocated intervention (n = 100)', 'otherNumAtRisk': 100, 'otherNumAffected': 13, 'seriousNumAtRisk': 100, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Infection rate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Serious'}], 'seriousEvents': [{'term': 'Hypoglycemia', 'notes': 'Hypoglycemia was defined as blood glucose \\< 60 mg/dl ( 3.3 mmol / l).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Serious'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Nosocomial Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tight Glycaemic Control (TGC)', 'description': 'Allocated to control group (n = 100)\n\n* Received allocated intervention (n = 99)\n* Did not receive allocated intervention: change operation (n = 1)'}, {'id': 'OG001', 'title': 'Conventional Glycaemic Control (Control)', 'description': 'Allocated to intensive group (n = 100)\n\n• Received allocated intervention (n = 100)'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within the first 30 day after surgery', 'description': 'Infection rate referred to the rate of nosocomial infection, including pneumonia, central line infection, surgical wound infection, deep sternal wound infection, urinary tract infection, and sepsis. Infections were defined according to the Centers for Disease Control and Prevention (CDC) definitions, occurring within 30 days postoperative cardiac surgery.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Morbidities and All Causes Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tight Glycaemic Control (TGC)', 'description': 'Allocated to control group (n = 100)\n\n* Received allocated intervention (n = 99)\n* Did not receive allocated intervention: change operation (n = 1)'}, {'id': 'OG001', 'title': 'Conventional Glycaemic Control (Control)', 'description': 'Allocated to intensive group (n = 100)\n\n• Received allocated intervention (n = 100)'}], 'classes': [{'title': 'Hypoglycemia', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Stroke', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'New atrial fibrillation', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Acute kidney injury', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Cardiac arrest', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within the first 30 days after surgery', 'description': 'morbidities defined as hypoglycaemia (blood sugar less than 60 mg/dL), Stroke (focal neurological deficit confirmed with CT or MRI), acute renal failure (rising of creatinine)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tight Glycaemic Control (TGC)', 'description': 'Allocated to intensive group (n = 100)\n\n* Received allocated intervention (n = 99)\n* Did not receive allocated intervention: change operation (n = 1)'}, {'id': 'FG001', 'title': 'Conventional Glycaemic Control (Control)', 'description': 'Allocated to control group (n = 100)\n\n• Received allocated intervention (n = 100)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Change operation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tight Glycaemic Control (TGC)', 'description': 'TGC used hyperinsulinaemic normoglycaemic clamp with modified glucose-insulin-potassium to control blood sugar. The insulin (HumulinTM R, Lilly pharma, Germany) was diluted with normal saline to the concentration 1 IU. mL-1 and was infused continuously throughout the operations at a fixed rate of 0.3 IU. kg-1.h-1 but the maximal rate was 20 IU/ h. A separate mixture of glucose 25% (A.N.B Laboratories, Thailand) 50 mL, potassium chloride (Nida pharma, Thailand) 20 mEq and magnesium sulfate (Atlantic, Thailand) 2 gm was infused at 0.75 mL.kg-1.h-1 and was adjusted to maintain blood glucose levels 80-150 mg/dL.'}, {'id': 'BG001', 'title': 'Conventional Glycaemic Control (Control)', 'description': 'Conventional glycaemic control aims to control blood sugar less than 250 mg%. Insulin was given bolusly if the blood sugar more than 250 mg%.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000', 'lowerLimit': '38.0', 'upperLimit': '63.5'}, {'value': '54', 'groupId': 'BG001', 'lowerLimit': '45.0', 'upperLimit': '65.2'}, {'value': '54', 'groupId': 'BG002', 'lowerLimit': '41.5', 'upperLimit': '65'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Mean body mass index (SD), kg/m^2', 'classes': [{'categories': [{'measurements': [{'value': '22.7', 'spread': '3.9', 'groupId': 'BG000'}, {'value': '23.3', 'spread': '4.4', 'groupId': 'BG001'}, {'value': '22.8', 'spread': '4.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoking status', 'classes': [{'title': 'Current', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'Former', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}, {'title': 'Never', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}]}, {'title': 'No data', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'New York Heart Association (NYHA) class', 'classes': [{'title': '1', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Class I: Cardiac disease, but no symptoms and no limitation in ordinary physical activity, Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity, Class III: Marked limitation in activity due to symptoms, even during less-than-ordinary activity, Class IV: Severe limitations. Experiences symptoms even while at rest.', 'unitOfMeasure': 'participants'}, {'title': 'American Society of Anesthesiologists (ASA) class', 'classes': [{'title': '3', 'categories': [{'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': '5', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'ASA classification defined according to American Society of Anesthesiologists that divided into 4 classes:\n\nASA class 1: healthy patient ASA class 2: mild systemic disease ASA class 3: uncontrolled systemic disease ASA class 4: incapacitated patient ASA class 5: moribund', 'unitOfMeasure': 'participants'}, {'title': 'Operation', 'classes': [{'title': 'Valve replacement / repairment', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}, {'title': 'Coronary artery bypass graft', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}, {'title': 'Closure of septal defects', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': "Bentall's operation", 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Aneurysmectomy of thoracic aortic aneurysm (TAA)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'More than 1 operation', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Others', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Case status', 'classes': [{'title': 'Elective', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}]}, {'title': 'Emergency', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Underlying disease:DM', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline and clinical characteristics of the study patients did not significantly differ between the two groups. There were 18 diabetic patients in the intensive group and 17 diabetic patients in the control group, and there was no difference in terms of the diabetic treatment given (P = 0.77).'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'whyStopped': 'Hypoglycaemia is significantly higher in TGC', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-15', 'studyFirstSubmitDate': '2010-07-29', 'resultsFirstSubmitDate': '2014-04-14', 'studyFirstSubmitQcDate': '2010-10-19', 'lastUpdatePostDateStruct': {'date': '2015-12-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-11-15', 'studyFirstPostDateStruct': {'date': '2010-10-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nosocomial Infection', 'timeFrame': 'within the first 30 day after surgery', 'description': 'Infection rate referred to the rate of nosocomial infection, including pneumonia, central line infection, surgical wound infection, deep sternal wound infection, urinary tract infection, and sepsis. Infections were defined according to the Centers for Disease Control and Prevention (CDC) definitions, occurring within 30 days postoperative cardiac surgery.'}], 'secondaryOutcomes': [{'measure': 'Morbidities and All Causes Mortality', 'timeFrame': 'within the first 30 days after surgery', 'description': 'morbidities defined as hypoglycaemia (blood sugar less than 60 mg/dL), Stroke (focal neurological deficit confirmed with CT or MRI), acute renal failure (rising of creatinine)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['tight glycemic control', 'cardiac surgery'], 'conditions': ['Nosocomial Infection', 'External Causes of Morbidity and Mortality', 'Hypoglycemia']}, 'descriptionModule': {'briefSummary': 'To determine whether intraoperative tight glycaemic control can reduce postoperative infection, morbidity and mortality', 'detailedDescription': 'Hyperglycaemia develops frequently in patients undergoing cardiac surgery, especially following cardiopulmonary bypass (CPB). Recent evidence suggests that acute hyperglycaemia adversely affects immune function, wound healing and cardiovascular function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 15 years\n* cardiac surgery with cardiopulmonary bypass\n\nExclusion Criteria:\n\n* active infection\n* insulin allergy\n* off-pump cardiopulmonary bypass procedures'}, 'identificationModule': {'nctId': 'NCT01225159', 'acronym': 'TGC', 'briefTitle': 'Tight Glycaemic Control During Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Prince of Songkla University'}, 'officialTitle': 'Safety and Efficacy of Tight Glycaemic Control During Cardiac Surgery', 'orgStudyIdInfo': {'id': 'SUB.EC 51-1008-08-1-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tight glycaemic control (TGC)', 'description': 'TGC used hyperinsulinaemic normoglycaemic clamp with modified glucose-insulin-potassium to control blood sugar. The insulin (HumulinTM R, Lilly pharma, Germany) was diluted with normal saline to the concentration 1 IU. mL-1 and was infused continuously throughout the operations at a fixed rate of 0.3 IU. kg-1.h-1 but the maximal rate was 20 IU/ h. A separate mixture of glucose 25% (A.N.B Laboratories, Thailand) 50 mL, potassium chloride (Nida pharma, Thailand) 20 mEq and magnesium sulfate (Atlantic, Thailand) 2 gm was infused at 0.75 mL.kg-1.h-1 and was adjusted to maintain blood glucose levels 80-150 mg/dL.', 'interventionNames': ['Drug: TGC']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Conventional glycaemic control (Control)', 'description': 'Conventional glycaemic control aims to control blood sugar less than 250 mg%. Insulin was given bolusly if the blood sugar more than 250 mg%.', 'interventionNames': ['Drug: Conventional glycaemic control']}], 'interventions': [{'name': 'TGC', 'type': 'DRUG', 'otherNames': ['intensive glycaemic control'], 'description': 'TGC used hyperinsulinaemic normoglycaemic clamp with modified glucose-insulin-potassium to control blood sugar. The insulin (HumulinTM R, Lilly pharma, Germany) was diluted with normal saline to the concentration 1 IU. mL-1 and was infused continuously throughout the operations at a fixed rate of 0.3 IU. kg-1.h-1 but the maximal rate was 20 IU/ h. A separate mixture of glucose 25% (A.N.B Laboratories, Thailand) 50 mL, potassium chloride (Nida pharma, Thailand) 20 mEq and magnesium sulfate (Atlantic, Thailand) 2 gm was infused at 0.75 mL.kg-1.h-1 and was adjusted to maintain blood glucose levels 80-150 mg/dL.', 'armGroupLabels': ['Tight glycaemic control (TGC)']}, {'name': 'Conventional glycaemic control', 'type': 'DRUG', 'otherNames': ['Control group'], 'description': 'Conventional glycaemic control aims to control blood sugar less than 250 mg%. Insulin was given bolusly if the blood sugar more than 250 mg%.', 'armGroupLabels': ['Conventional glycaemic control (Control)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90110', 'city': 'Hat Yai', 'state': 'Changwat Songkhla', 'country': 'Thailand', 'facility': 'Songklanagarind Hospital, Faculty of Medicine, PSU', 'geoPoint': {'lat': 7.00836, 'lon': 100.47668}}], 'overallOfficials': [{'name': 'Panthila Rujirojindakul, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine, Prince of Songkla University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prince of Songkla University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Panthila Rujirojindakul', 'investigatorAffiliation': 'Prince of Songkla University'}}}}