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IRCT20190304042918N1 IRCT 2019-04-27 Ahvaz University of Medical Sciences Effect of Taurolock in prevention of catheter infection and dysfunction Comparing the efficacy of Taurolock and Saline 5% in prevention of hemodialysis catheter infection and dysfunction 2019-03-15 anticipated 68 Complete https://irct.ir/trial/38055 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be randomly assigned into two groups of experimental and control. Each patient is given a number from 1 to 64 and assignment of patients into the study groups will be done by table of random numbers, Blinding description: The patients will not know about grouping and type of intervention (receiving either Taurolock or Saline). Taurolock and saline are placed in the same package (with special code) so that the participants do not understand which group they belong to. 2 Catheter-related infection. Intervention 1: Intervention group: Salin5% will be injected into the lumen of the catheter after each hemodialysis session and catheter locked. Intervention 2: Intervention group: In this group, will be used Taurolock (TauroLock™-Hep 500®) solution as lock antibiotic. Taurolock vial containing taurolidine (antimicrobial agent), 500 units heparin per mL and citrate 4%. lock solution will be injected into the lumen of the catheter after each hemodialysis session and catheter locked. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Ali Ghirbani
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
Ahvaz Iran (Islamic Republic of) 6135733118 +98 61 3001 3374 Ali.ghorbani.001@gmail.com Ahvaz University of Medical Sciences scientific Ali Ghirbani
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
Ahvaz Iran (Islamic Republic of) 6135733118 +98 61 3001 3374 Ali.ghorbani.001@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Patients with chronic kidney disease requiring dialysis with tunneled hemodialysis catheter Age over 18 years Consent to participate in the study 18 years no limit Both Using the central venous catheters for anything other than haemodialysis A49.9 Bacterial infection, unspecified Prevention Prevention Intervention group: Salin5% will be injected into the lumen of the catheter after each hemodialysis session and catheter locked Intervention group: In this group, will be used Taurolock (TauroLock™-Hep 500®) solution as lock antibiotic. Taurolock vial containing taurolidine (antimicrobial agent), 500 units heparin per mL and citrate 4%. lock solution will be injected into the lumen of the catheter after each hemodialysis session and catheter locked Catheter-related infection. Timepoint: After each session hemodialysis for 3 months. Method of measurement: Clinical examination of infection and blood culture. Catheter-related dysfunction. Timepoint: In each session of hemodialysis for 3 months. Method of measurement: Blood flow less than 250 cc/min through the CVC. Ahvaz University of Medical Sciences Approved 2018-09-15 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd. Ahvaz Khouzestan Iran (Islamic Republic of)