Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-04-17 @ 6:01 AM
Study NCT ID:
NCT03373266
Status:
COMPLETED
Last Update Posted:
2017-12-14
First Post:
2017-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serun Fluoride and Kidney Transplant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077149', 'term': 'Sevoflurane'}, {'id': 'D007530', 'term': 'Isoflurane'}], 'ancestors': [{'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-13', 'studyFirstSubmitDate': '2017-12-02', 'studyFirstSubmitQcDate': '2017-12-13', 'lastUpdatePostDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum fluoride', 'timeFrame': 'baseline before anesthesia', 'description': 'Serum inorganic fluoride'}, {'measure': 'Serum fluoride', 'timeFrame': 'one hour postoperative', 'description': 'Serum inorganic fluoride'}, {'measure': 'serum fluoride', 'timeFrame': '6 hours postoperative', 'description': 'Serum inorganic fluoride'}, {'measure': 'Serum fluoride', 'timeFrame': '12 hours postoperative', 'description': 'Serum inorganic fluoride'}, {'measure': 'Serum fluoride', 'timeFrame': '24 hours postoperative', 'description': 'Serum inorganic fluoride'}, {'measure': 'Serum fluoride', 'timeFrame': '48 hours postoperative', 'description': 'Serum inorganic fluoride'}], 'secondaryOutcomes': [{'measure': 'Serum creatinine', 'timeFrame': 'Baseline preoperative', 'description': 'kidney function'}, {'measure': 'Serum creatinine', 'timeFrame': '24 hours postoperative', 'description': 'kidney function'}, {'measure': 'Serum creatinine', 'timeFrame': '48 hours postoperative', 'description': 'kidney function'}, {'measure': 'Serum creatinine', 'timeFrame': 'one week postoperative', 'description': 'kidney function'}, {'measure': 'creatinine clearance', 'timeFrame': 'baseline before anesthesia', 'description': 'kidney function'}, {'measure': 'creatinine clearance', 'timeFrame': '24 hours postoperative', 'description': 'kidney function'}, {'measure': 'creatinine clearance', 'timeFrame': '48 hours postoperative', 'description': 'kidney function'}, {'measure': 'creatinine clearance', 'timeFrame': 'one week postoperative', 'description': 'kidney function'}, {'measure': 'Urine output', 'timeFrame': '24 hours postoperative', 'description': 'kidney function'}, {'measure': 'Urine output', 'timeFrame': '48hours postoperative', 'description': 'kidney function'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Transplant; Complications']}, 'referencesModule': {'references': [{'pmid': '8050420', 'type': 'BACKGROUND', 'citation': 'Burchardi H, Kaczmarczyk G. The effect of anaesthesia on renal function. Eur J Anaesthesiol. 1994 May;11(3):163-8.'}]}, 'descriptionModule': {'briefSummary': 'Our primary goal is to investigate any hidden burden upon the grafted kidney from the increase of serum fluoride resulted from sevoflurane, versus isoflurane.', 'detailedDescription': 'Eighty patients with end stage renal failure undergoing living donor kidney transplant under general anesthesia were included in this study, by using an open (non-blinded) study design, patients were randomly assigned to two groups, 15 patients in each. Randomization was done through computer generated random tables. Isoflurane group; anesthesia was maintained with isoflurane 1-2%. Sevoflurane group; anesthesia was maintained with Sevoflurane 1-2%.\n\nA peripheral intravenous access was secured in the hand opposite to the functioning fistula and induction of anesthesia was done with propofol 2mg/kg, neuromuscular blockade was maintained with atracurium 0.6mg/kg and all patients were intubated and ventilated to maintain end-tidal carbon dioxide (ETCO2) concentration between 30-40 mmHg. Anaesthesia was maintained with 1-2% isoflurane (isoflurane group) or 1-2% sevoflurane (sevoflurane group) with fresh gas flow of 2 L/min. In both groups inhalational anesthetic was delivered in an air-oxygen mixture of 1:1 ratio. Analgesia was maintained with fentanyl 1µg/kg/hr. Mannitol and sodium bicarbonate was given immediately before reperfusion (de-clamping of renal artery). Intraoperative monitoring included heart rate, noninvasive blood pressure, oxygen saturation, ETCO2, ECG and central venous line was placed in the right or left internal jugular vein depending upon the presence of dialysis catheter. Hemodynamic target include: mean arterial pressure of \\> 80mmHg, CVP between 10-15 mm Hg to optimize cardiac output and renal blood flow.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* end stage renal disease\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03373266', 'briefTitle': 'Serun Fluoride and Kidney Transplant', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Implication of Serum Fluoride Level Caused by Sevoflurane Versus Isoflurane Anesthesia Upon Renal Function After Kidney Transplantation.', 'orgStudyIdInfo': {'id': 'IRB0000871242'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sevoflurane', 'description': 'anesthesia was maintained with Sevoflurane 1-2%.', 'interventionNames': ['Drug: Sevoflurane']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'isoflurane', 'description': 'anesthesia was maintained with isoflurane 1-2%.', 'interventionNames': ['Drug: Isoflurane']}], 'interventions': [{'name': 'Sevoflurane', 'type': 'DRUG', 'otherNames': ['Inhalational anesthetic'], 'description': 'anesthesia was maintained with Sevoflurane 1-2%.', 'armGroupLabels': ['Sevoflurane']}, {'name': 'Isoflurane', 'type': 'DRUG', 'otherNames': ['Inhalational anesthetic'], 'description': 'anesthesia was maintained with isoflurane 1-2%.', 'armGroupLabels': ['isoflurane']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut university faculty of medicine', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Abdelrady S Ibrahim, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'assiut university faculty of medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Abdelrady S Ibrahim, MD', 'investigatorAffiliation': 'Assiut University'}}}}