Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-31 @ 1:32 PM
Study NCT ID:
NCT05205304
Status:
UNKNOWN
Last Update Posted:
2022-04-05
First Post:
2022-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Transdermal CO2 in MDA Level in Patient Underwent Abdominal Aortic Temporary Cross Clamp
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010921', 'term': 'Placenta Accreta'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D010922', 'term': 'Placenta Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects will be divided into two groups. The first group is treated with CO2 transdermal administration and the second group is the control group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-03', 'studyFirstSubmitDate': '2022-01-03', 'studyFirstSubmitQcDate': '2022-01-24', 'lastUpdatePostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Malondyaldehyde', 'timeFrame': 'Basal, 1 hour after aortic cross clamp off', 'description': "The malondyaldehyde concentration of the patient's serum measured by ELISA test method"}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Abdominal Aortic Cross Clamp'], 'conditions': ['Placenta Accreta']}, 'descriptionModule': {'briefSummary': 'The Role of Transdermal Carbon Dioxide in Malondialdehyde Level as Predictor of Ischemia Reperfusion Injury in Patients Underwent Abdominal Aortic Temporary Cross Clamp', 'detailedDescription': 'Abdominal aortic temporary cross clamping procedures in patients with placenta accreta undergoing hysterectomy have been performed at Dr. Soetomo Hospital Surabaya for a period of 4 years. In the aortic cross-clamping procedure, an ischemic condition occurs, after the cross-clamp is released the distal tissue from the occlusion which was initially in an ischemic state gets blood flow suddenly (reperfusion) causing Ischemia Reperfusion Injury. This study aims to determine the effect of transdermal administration of carbon dioxide (CO2) as a protective factor for ischemia reperfusion injury in patients undergoing Abdominal Aorta Temporary Cross Clamp. The design of this study is experimental in patients who underwent Abdominal Aorta Temporary Cross Clamp. Subjects were divided into two groups. The first group was treated with CO2 transdermal administration and the second group was the control group.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Placenta Accreta diagnosed with placental accreta index (PAI) based on the results of ultrasound and underwent Abdominal Aorta Clamping Surgery (Control of Bleeding in Accreta)\n\nExclusion Criteria:\n\n* Patients with severe comorbid disorders based on previous clinical examination: chronic kidney disease, heart disease\n* Patients with septic shock and sepsis\n* Patients with peripheral artery disease'}, 'identificationModule': {'nctId': 'NCT05205304', 'briefTitle': 'The Role of Transdermal CO2 in MDA Level in Patient Underwent Abdominal Aortic Temporary Cross Clamp', 'organization': {'class': 'OTHER', 'fullName': 'Universitas Airlangga'}, 'officialTitle': 'The Role of Transdermal Carbon Dioxide in Malondialdehyde Level as Predictor of Ischemia Reperfusion Injury in Patients Underwent Abdominal Aortic Temporary Cross Clamp', 'orgStudyIdInfo': {'id': 'TCVS UA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': "Subjects will be treated with liquid carbon dioxide (D'oxyva) administered transdermally on the thumb after the Aortic Cross Clamp is removed", 'interventionNames': ["Drug: D'Oxyva"]}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': "Subject will not be treated with liquid carbon dioxide (D'oxyva)"}], 'interventions': [{'name': "D'Oxyva", 'type': 'DRUG', 'otherNames': ['Transdermal CO2'], 'description': "The transdermal CO2 was administered via non-invasive vaporization technique accommodated by deoxyhemoglobin vasodilator (D'Oxyva)", 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80116', 'city': 'Surabaya', 'state': 'Bali', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Hari D Pagehgiri, MD', 'role': 'CONTACT', 'email': 'hari.daswin.pagehgiri-2016@fk.unair.ac.id', 'phone': '081933118881'}], 'facility': 'Hari Daswin Pagehgiri'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitas Airlangga', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident of Thoracic, Cardiac, and Vascular Surgery Department', 'investigatorFullName': 'Hari Daswin Pagehgiri', 'investigatorAffiliation': 'Universitas Airlangga'}}}}