Nctid:
NCT06611189
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D007674", "term"=>"Kidney Diseases"}, {"id"=>"D051436", "term"=>"Renal Insufficiency, Chronic"}], "ancestors"=>[{"id"=>"D014570", "term"=>"Urologic Diseases"}, {"id"=>"D052776", "term"=>"Female Urogenital Diseases"}, {"id"=>"D005261", "term"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D052801", "term"=>"Male Urogenital Diseases"}, {"id"=>"D051437", "term"=>"Renal Insufficiency"}, {"id"=>"D002908", "term"=>"Chronic Disease"}, {"id"=>"D020969", "term"=>"Disease Attributes"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M10698", "name"=>"Kidney Diseases", "asFound"=>"Kidney Disease", "relevance"=>"HIGH"}, {"id"=>"M10543", "name"=>"Ischemia", "relevance"=>"LOW"}, {"id"=>"M26717", "name"=>"Renal Insufficiency, Chronic", "asFound"=>"Chronic Kidney Disease", "relevance"=>"HIGH"}, {"id"=>"M26718", "name"=>"Renal Insufficiency", "relevance"=>"LOW"}, {"id"=>"M17319", "name"=>"Urologic Diseases", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M27093", "name"=>"Female Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M14127", "name"=>"Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M8399", "name"=>"Female Urogenital Diseases and Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M27095", "name"=>"Male Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M6147", "name"=>"Chronic Disease", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M21860", "name"=>"Pharmaceutical Solutions", "relevance"=>"LOW"}, {"id"=>"M4854", "name"=>"Benzocaine", "relevance"=>"LOW"}, {"id"=>"T433", "name"=>"Tannic Acid", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Pharmaceutical Solutions", "abbrev"=>"PhSol"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"Other Dietary Supplements", "abbrev"=>"Ot"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>172}, "targetDuration"=>"6 Months", "patientRegistry"=>true}, "statusModule"=>{"overallStatus"=>"ACTIVE_NOT_RECRUITING", "startDateStruct"=>{"date"=>"2020-01-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-01-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-20", "studyFirstSubmitDate"=>"2024-09-10", "studyFirstSubmitQcDate"=>"2024-09-20", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-24", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-01-01", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Creatinine decrease", "timeFrame"=>"6 months", "description"=>"Serum creatinine levels at 7th, 30th, 60th, and 180th days after operation were evaluated"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Kidney transplantation", "Warm ischemia"], "conditions"=>["Chronic Kidney Disease Stage V"]}, "referencesModule"=>{"references"=>[{"pmid"=>"31266437", "type"=>"BACKGROUND", "citation"=>"Ferede AA, Walsh AL, Davis NF, Smyth G, Mohan P, Power R, Forde J, O'Kelly P, Llittle D. Warm Ischemia Time at Vascular Anastomosis is an Independent Predictor for Delayed Graft Function in Kidney Transplant Recipients. Exp Clin Transplant. 2020 Feb;18(1):13-18. doi: 10.6002/ect.2018.0377. Epub 2019 Jul 2."}, {"pmid"=>"37028949", "type"=>"BACKGROUND", "citation"=>"Ide K, Sakai H, Nakano R, Imaoka Y, Tanimine N, Ide R, Tsukiyama N, Ono K, Mochizuki T, Arata R, Hakoda K, Imaoka K, Fukuhara S, Bekki T, Tahara H, Ohira M, Kobayashi E, Ohdan H. Effectiveness of Thermal Barrier Bag for Prolonged Vascular Anastomosis in Kidney Transplantation. Transplant Proc. 2023 May;55(4):752-755. doi: 10.1016/j.transproceed.2023.03.004. Epub 2023 Apr 6."}, {"pmid"=>"36845857", "type"=>"BACKGROUND", "citation"=>"Ide K, Nakano R, Imaoka Y, Sakai H, Ono K, Tanimine N, Tahara H, Ohira M, Ueda K, Hirata T, Kobayashi E, Ohdan H. Protection From Second Warm Ischemic Injury Using a Thermal Barrier Bag in Kidney Transplantation. Transplant Direct. 2023 Feb 17;9(3):e1454. doi: 10.1097/TXD.0000000000001454. eCollection 2023 Mar."}]}, "descriptionModule"=>{"briefSummary"=>"Warm ischemia during kidney transplantation is one of the important factors that negatively affect kidney function in the recipient. The investigators aimed to examine the effects of two techniques (Ray-Tech sponge technique and Ice bag technique) applied to protect the kidney from warm ischemia during kidney transplantation on long-term kidney function.", "detailedDescription"=>"A prospective, randomized clinical trial was conducted at Istanbul Okan University Hospital, Istanbul, Turkey. All participants were selected from those who underwent kidney transplantation between January 2020 and January 2023."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"All individuals were selected from those who underwent Kidney transplantation at our institution between January 2020 and January 2023.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n-Underwent kidney transplantation surgery\n\nExclusion Criteria:\n\n- Deceased donor transplantation"}, "identificationModule"=>{"nctId"=>"NCT06611189", "briefTitle"=>"A Comparative Analysis of Ray-Tech Sponge and Ice Bag Techniques in Kidney Transplantation", "organization"=>{"class"=>"OTHER", "fullName"=>"Okan University"}, "officialTitle"=>"A Comparative Analysis of Ray-Tech Sponge and Ice Bag Techniques in the Elimination of Warm Ischemic Time in Kidney Transplantation", "orgStudyIdInfo"=>{"id"=>"No: 161, Date: December 14, 20"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Group A", "description"=>"Kidney transplantation performed using the ice bag technique.", "interventionNames"=>["Other: surgery"]}, {"label"=>"Group B", "description"=>"Kidney transplantation performed using Raytech sponge technique.", "interventionNames"=>["Other: Ray-Tech sponge technique"]}], "interventions"=>[{"name"=>"surgery", "type"=>"OTHER", "otherNames"=>["Simple plastic bag to preserve kidney from warm ischemia"], "description"=>"In order to preserve kidney from warm ischemia during graft implantation, on the back table, graft were prepared for implantation with standard techniques. The kidney was introduced into the bag which was filled with a small amount of ice and preservation fluid (Figure 1). After inplacement of the graft, a small hole was made near the hilum and the renal artery and vein were passed through the hole. A Kocher clamp was used to maintain the fluid and ice in place and as a handle. Also, a Hartman Mosquito Clamp was used to mark urether-side, and to maintain orientation.", "armGroupLabels"=>["Group A"]}, {"name"=>"Ray-Tech sponge technique", "type"=>"OTHER", "description"=>"On the back table, graft were prepared for implantation with standard techniques. A Raytech sponge is soaked in ice-cold preservative solution, and wrapped around the kidney and held with a clamp (Figure 2). Position and oriantation of the graft was done by direct vision of urether.", "armGroupLabels"=>["Group B"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"34734", "city"=>"Istanbul", "state"=>"Kadıköy", "country"=>"Turkey", "facility"=>"Murat Ferhat Ferhatoglu", "geoPoint"=>{"lat"=>41.01384, "lon"=>28.94966}}, {"zip"=>"34334", "city"=>"Istanbul", "country"=>"Turkey", "facility"=>"Istanbul Okan University", "geoPoint"=>{"lat"=>41.01384, "lon"=>28.94966}}], "overallOfficials"=>[{"name"=>"MURAT F FERHATOGLU, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Okan University"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO", "description"=>"Sharing data is not right in terms of patient privacy. When the informed consent form was signed by participants, only information about the study was given. No information was given about data sharing."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Okan University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principal Investigator", "investigatorFullName"=>"Murat Ferhat Ferhatoglu", "investigatorAffiliation"=>"Okan University"}}}}
