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IRCT20210921052544N1 IRCT 2022-05-01 Shahid Beheshti University of Medical Sciences Evaluation of Preventive Protocol for Central Venous Catheter-Related Infection (Antibiotic Lock Therapy and TauroLock) in Hemodialysis Patients. Efficacy of Preventive Protocol for Central Venous Catheter-Related Infection (Antibiotic Lock Therapy and TauroLock) in Hemodialysis Patients. 2022-04-20 anticipated 60 Complete https://irct.ir/trial/59578 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The case-study patients are randomized into two groups. The allocation of patients in the two groups had been based on demographic characteristics and their assimilation. Accordingly, after the patients were divided into two equal groups in terms of number based on demographic information, we included the patients in the study and performed the desired intervention on them. In this study, taurolock- manufactured by Tauropharm Gmbh Company- and the combination of vancomycin with heparin- manufactured by Exir Pharmaceutical Company- are visually numbered in similar ampoules and only the person in charge of the study knows the contents. The drugs are distributed in the dialysis center. Neither of nurse in charge and the patient know about the type of solution. Each patient is assigned an ID sheet contained the patient's details and the number of the solution of the received drug. Patients receive the solution randomly each time they are being on dialysis. The randomization method is simple and the randomization unit is the person who numbers the used ampoules in the random number table, Blinding description: In this way, patients in the two groups, analyzer and outcome assessor, do not know about the drug used and the packaging of drugs is done in the same way. 3 Condition 1: Catheter infection. Condition 2: Hemodyalisis. Intervention 1: Intervention group one( Taurolock manufactured by TauroPharm GmbH Company): At the end of each dialysis, the patient's premcath lines are filled with taurolock and each month blood culture sample is prepare from the patient's premcath lines.Also blood culture sample is prepared from peripheral blood and permacath in the case of symptoms of infection. Intervention 2: Intervention group two(Antibiotic lock-combination of vancomycin and heparin manufactured by Exir Pharmaceutical Company):At the end of each dialysis, the patient's premcath lines are filled with antibiotic lock and each month blood culture sample is prepare from the patient's premcath lines.Also blood culture sample is prepared from peripheral blood and permacath in the case of symptoms of infection. No - There is not a plan to make this available Justification or reason for not sharing IPD is The information will be published as a result of the analysis.
public Maryam Delgosha
Imam Hussein Hospital - Shahid madani ave - Imam Hussein square
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 mary.delgosha@gmail.com Shahid Beheshti University of Medical Sciences scientific Nassiri Amirahmmad
Imam Hussein Hospital - Shahid madani ave - Imam Hussein square
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 nassirimorad@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) All End Stage Renal Disease patients dialysis through permacath Presenting informed consent for attending in study 18 years no limit Both Poor blood flow during dialysis Past history of IV drug abusing Past history of active systemic infections before permacath insertion Change the catheter to AV fistula Past surgical history whitin the last year Past history of allergies to antibiotics T80.211A N18.5 Bloodstream infection due to central venous catheter, initial encounter Chronic kidney disease, stage 5 Prevention Prevention Intervention group one( Taurolock manufactured by TauroPharm GmbH Company): At the end of each dialysis, the patient's premcath lines are filled with taurolock and each month blood culture sample is prepare from the patient's premcath lines.Also blood culture sample is prepared from peripheral blood and permacath in the case of symptoms of infection. Intervention group two(Antibiotic lock-combination of vancomycin and heparin manufactured by Exir Pharmaceutical Company):At the end of each dialysis, the patient's premcath lines are filled with antibiotic lock and each month blood culture sample is prepare from the patient's premcath lines.Also blood culture sample is prepared from peripheral blood and permacath in the case of symptoms of infection. The rate of catheter infection in hemodialysis patients. Timepoint: Checking blood culture from catheter lines and peripheral blood at the end of each month. Method of measurement: Culture of catheter lines and peripheral blood. Shahid Beheshti University of Medical Sciences Approved 2021-03-06 Ethics committee of Shahid Beheshti University of Medical Sciences Next to Ayatollah Taleghani Hospital -Shahid Arabi Street -Yemen Street - Shahid Chamran highway - Tehran Tehran Tehran Iran (Islamic Republic of)