Nctid:
NCT06230042
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-02"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000014552", "term"=>"Urinary Tract Infections"}], "ancestors"=>[{"id"=>"D000014570", "term"=>"Urologic Diseases"}, {"id"=>"D000052776", "term"=>"Female Urogenital Diseases"}, {"id"=>"D000005261", "term"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000052801", "term"=>"Male Urogenital Diseases"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M17302", "name"=>"Urinary Tract Infections", "asFound"=>"Urinary Tract Infections", "relevance"=>"HIGH"}, {"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"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"TRIPLE", "whoMasked"=>["PARTICIPANT", "INVESTIGATOR", "OUTCOMES_ASSESSOR"], "maskingDescription"=>"The participant, the investigator and the outcomes assessor were all masked. Only the care provider who performed the anaesthesia were not blinded but they were not involved in the subsequent prostate biopsy, pain assessment, data collection and data analysis."}, "primaryPurpose"=>"OTHER", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>80}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-02-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-02-15", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-27", "studyFirstSubmitDate"=>"2024-01-18", "studyFirstSubmitQcDate"=>"2024-01-27", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-02-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Catheter-Associated Urinary Tract Infection (CAUTI) Incidence", "timeFrame"=>"the Day 3,Day 7, Day 10 and Day 14 after catheterization", "description"=>"The mid-stream urine specimens on the 3rd, 7th, 10th and 14th days after catheterization were taken for bacterial culture to compare the incidence of urinary tract infections in the two groups at different times of indwelling urinary catheterization.\n\nDiagnostic criteria: patients with urinary tract infections that occurred after indwelling urinary catheterization, or within 48 h of catheter removal. Urine bacterial culture of Gram-positive cocci colonies ≥104cfu/ml and Gram-negative bacilli colonies ≥105cfu/ml was judged as urinary tract infection."}, {"measure"=>"Crystal deposits on the inner wall of the catheter", "timeFrame"=>"Day 14 after catheterization", "description"=>"① After removing the urinary catheter, a 1-cm section was taken from the head end and the center of each urinary catheter, and the crystal deposition inside the catheter was observed using a scanning electron microscope, and the average scores of the two groups were calculated according to the scores in the table below, comparing the effectiveness of the two groups of urinary catheters in preventing crystallization. ② Record the details and number of blockages that occurred during the indwelling catheterization period, and calculate the blockage rate of the two groups."}], "secondaryOutcomes"=>[{"measure"=>"Evaluation of urethral irritation response", "timeFrame"=>"Day 1 after catheterization", "description"=>"Patients were asked about their feelings after 24h of indwelling catheterization, and the occurrence of urethral irritation reaction was recorded according to their subjective feelings."}, {"measure"=>"Measuring the temperature of bladder urine", "timeFrame"=>"the Day 3,Day 7, Day 10 and Day 14 after catheterization", "description"=>"The temperature of bladder urine was detected and recorded by connecting the machine end of the temperature measuring probe to the corresponding interface of the monitor on the 3rd, 7th, 10th, and 14th days after the patient's indwelling urinary catheter."}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["urinary tract infections", "urinary tract crystallization"], "conditions"=>["Urinary Catheter"]}, "descriptionModule"=>{"briefSummary"=>"This is a single-center randomized controlled trial in comparison of Parylene-Coated versus Silicone Catheters in the Prevention of Urinary Tract Infections and Crystallization.", "detailedDescription"=>"This study was a single-center randomized controlled trial, enrolling patients with indwelling urinary catheterization time greater than 2 weeks, and comparing the incidence of urinary tract infections in the two groups with different indwelling urinary catheter times by retaining mid-stream urine specimens for bacterial cultures on the 3rd, 7th, 10th, and 14th days after urinary catheter placement. And after removal of the urinary catheter,1-cm sections were taken from the head end and center of each urinary catheter, and the crystal deposition inside the catheter was observed using a scanning electron microscope. The incidence of urinary tract infections and crystal deposition on the inner wall of the catheter were compared between the patients in the matte catheter group (Parylene-coated) and the patients in the glossy catheter group (plain silicone) during the period of catheterization, so as to evaluate the effectiveness of the two types of catheters in the clinical application."}, "eligibilityModule"=>{"sex"=>"MALE", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. age greater than 18 years;\n2. indwelling urinary catheter for ≥14 days;\n3. fully understand the clinical trial protocol and sign the informed consent;\n\nExclusion Criteria:\n\n1. patients with confirmed urinary tract infection before indwelling urinary catheter;\n2. those with renal dysfunction;\n3. those who are allergic to silicone or silicone material;\n4. those with low immunity susceptible to infection;\n5. those who have participated in other clinical trials within 3 months;\n6. others who are judged by the investigator to be unsuitable for clinical trials;"}, "identificationModule"=>{"nctId"=>"NCT06230042", "briefTitle"=>"Catheter in the Prevention of Urinary Tract Infections and Crystallization Study(CPUTICS)", "organization"=>{"class"=>"OTHER", "fullName"=>"Shanghai East Hospital"}, "officialTitle"=>"Parylene-Coated Versus Silicone Catheters in the Prevention of Urinary Tract Infections and Crystallization: A Single-Center Randomized Controlled Trial", "orgStudyIdInfo"=>{"id"=>"CPUTICS-01"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Parylene-Coated Catheter", "description"=>"The type of catheter used during a patient's indwelling urinary catheterization is Parylene-Coated Catheter", "interventionNames"=>["Other: Types of catheters"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Silicone Catheter", "description"=>"The type of catheter used during a patient's indwelling urinary catheterization is Silicone Catheter", "interventionNames"=>["Other: Types of catheters"]}], "interventions"=>[{"name"=>"Types of catheters", "type"=>"OTHER", "description"=>"One type of catheters were used for patients", "armGroupLabels"=>["Parylene-Coated Catheter", "Silicone Catheter"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"200120", "city"=>"Shanghai", "country"=>"China", "contacts"=>[{"name"=>"shuaidong wang", "role"=>"CONTACT", "email"=>"wangshuaidong_wsd@163.com", "phone"=>"15102100859"}, {"name"=>"haifeng wang", "role"=>"CONTACT", "email"=>"kuohaiandrew2000@vip.sina.com.cn", "phone"=>"13681750891"}], "facility"=>"Shanghai East Hospital, Tongji University School of Medicine", "geoPoint"=>{"lat"=>31.22222, "lon"=>121.45806}}], "centralContacts"=>[{"name"=>"shuaidong wang", "role"=>"CONTACT", "email"=>"wangshuaidong_wsd@163.com", "phone"=>"15102100859"}, {"name"=>"haifeng wang", "role"=>"CONTACT", "email"=>"kuohaiandrew2000@vip.sina.com.cn", "phone"=>"13681750891"}], "overallOfficials"=>[{"name"=>"haifeng wang", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Shanghai East Hospital,Tongji University School of Medicine"}]}, "ipdSharingStatementModule"=>{"infoTypes"=>["STUDY_PROTOCOL", "SAP", "ICF", "CSR", "ANALYTIC_CODE"], "timeFrame"=>"Data will become available after publication with no end date", "ipdSharing"=>"YES", "description"=>"Once available, the results of this trial will be disseminated to an international peer-reviewed journal and presentations at international or national academic conferences. The data will be made available upon request to researchers a) who provide a methodologically sound proposal and b) whose proposed use of the data has been approved by an independent ethical review committee."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Shanghai East Hospital", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
