Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-01-21 @ 4:38 PM
Study NCT ID:
NCT05687669
Status:
UNKNOWN
Last Update Posted:
2023-01-18
First Post:
2022-12-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between the Use of Phentolamine Versus Glyceryl Trinitrate for Their Effect on Renal Function in Pre-eclampsia Patients in ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Group(A): Glyceryl trinitrate (GTN) is labelled with "Drug A" on syringe pump. Group(B): Phentolamine is labelled with "Drug B" on syringe pump.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective study will be done in Assiut university hospital obstetric ICU, 2 groups will be examined and randomly assigned: group A using glyceryl trinitrate (GTN) to emergency control of blood pressure and group B using phentolamine infusion to control blood pressure. Each group consists of 85patients:'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 170}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-01-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-06-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-07', 'studyFirstSubmitDate': '2022-12-07', 'studyFirstSubmitQcDate': '2023-01-07', 'lastUpdatePostDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'kidney function tests', 'timeFrame': '96 hours after intervention', 'description': 'creatinine in micromoles per liter and urea in millimole per liter'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pre-Eclampsia; Complicating Pregnancy', 'Pre-eclampsia Aggravated']}, 'descriptionModule': {'briefSummary': 'Severe pre-eclamptic toxemia has a high incidence of renal complications. Rapid diagnosis and termination of pregnancy are still the gold standard main treatment for pre-eclampsia. Rapid control of blood pressure showed to provide protection against many adverse effects of preeclampsia as intracranial hemorrhage, subcapsular hepatic hematoma and acute kidney injury (AKI).\n\nIn Assiut university hospital ICU regimen, glyceryl trinitrate (GTN) was used primarily for this purpose. But it was accused in many cases as a cause for AKI without any other organ damage along with the severe preeclampsia disease. Some previous studies supported this assumption as , Ying-Hsuan .T. et.,al during their study of GTN on renal outcome during cardiopulmonary bypass in cardiac surgery. Phentolamine infusion is a new rising alternative for an old drug with a high safety profile.\n\nIn this research protocol the researchers will study comparative effect of glyceryl trinitrate (GTN) versus phentolamine on renal outcome in severe pre-eclampsia patients during their stay in obstetric ICU.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'genderDescription': 'only in preeclampsia patients which is complicating pregnancy in females', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Severe preeclampsia defined by presentation of 2 or more of the following criteria:\n\n 1. Blood pressure more than 160/100\n 2. Proteinuria\n 3. Pitting edema\n 4. With or without organ dysfunctions\n\nExclusion Criteria:\n\n1. Patient relatives' refusal\n2. Recent active internal hemorrhage\n3. Chronic renal impairment or failure on dialysis for any other etiology"}, 'identificationModule': {'nctId': 'NCT05687669', 'briefTitle': 'Comparison Between the Use of Phentolamine Versus Glyceryl Trinitrate for Their Effect on Renal Function in Pre-eclampsia Patients in ICU', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Comparison Between the Use of Phentolamine Versus Glyceryl Trinitrate for Their Effect on Renal Function in Pre-eclampsia Patients in ICU', 'orgStudyIdInfo': {'id': 'obstetric Renal prophylaxis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group GTN', 'description': 'Glyceryl trinitrates (GTN) is infused to patients with severe hypertensive preeclampsia till oral anti-hypertensives and Magnesium sulfate loadings lower blood pressure', 'interventionNames': ['Drug: Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment']}, {'type': 'EXPERIMENTAL', 'label': 'Group Phentolamine', 'description': 'Phentolamine is infused to patients with severe hypertensive preeclampsia till oral anti-hypertensives and Magnesium sulfate loadings lower blood pressure', 'interventionNames': ['Drug: Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment']}], 'interventions': [{'name': 'Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment', 'type': 'DRUG', 'description': 'Glyceryl trinitrate vs phentolamine for prophylaxis against renal impairment', 'armGroupLabels': ['Group GTN', 'Group Phentolamine']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Ayman Abd El-Khalek Mohammed Glala', 'investigatorAffiliation': 'Assiut University'}}}}