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IRCT20100127003210N18 IRCT 2019-09-09 Shahid Beheshti University of Medical Sciences Effect of Vancomycin as antibiotic lock technique in prevention of catheter associated infection in stem cell transplantation patientsV Effect of Vancomycin as antibiotic lock technique in prevention of catheter associated infection in stem cell transplantation patients 2019-11-22 anticipated 60 Complete https://irct.ir/trial/36518 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Permuted Block Randomization The randomization scheme consists of a sequence of blocks such that each block contains 10 number of intervention assignments in random order. The BMT ward of Taleghani Hospital consisted of two nursing station (S1 and S2). In one station (S1), heparin plus vancomycin lock will be performed and in the other station, heparin lock will be done on patients. Equal allocation wil be planned in a two-armed trial (S1 and S2) using a randomization scheme of permuted blocks. Investigator plans to enroll 10 subjects per month. Individuals in this group were randomly assigned to one the two aforementioned nursing stations. Randomization will be done to generate random sequences on the web (http://www.graphpad.com/quick calc /index.cfm). Each patient will go to one of the station based on randomization sequence. Block will be done for 21 days from catheterization day. Allocation concealment randomization will done from a SNOSE method, and will be kept by the hospital pharamcist of the two stations, Blinding description: Patients will be unaware of their allocated group. 2-3 catheter- related Blood stream infection (CRBSI). Intervention 1: Intervention group (5 mg vancomycin, 2500 IU/ml heparin): Every night at a certain time, patients in the intervention group receive the block solution (vacomycin-heparin) . This block is done for each patient in a 21- day time interval from the day of catheterization. The block time is at least 8 hours but depending on catheter availability it may increase. When dwell time is over, researcher aspirates antibiotic lock solution from catheter lumen, flush catheter with 5ml normal saline before using line to administer medication.This process is done by the trained nurse. Lock solution is prepared based on it’s stability every 72 hour by pharmacist. Solution vancomycin-heparin stable 72 hours in room temperature based on Antibiotic Lock solution Therapy Guideline. Intervention 2: Control group (Heparin only 100IU/ml base on routine program in ward): This block is done for each patient in a 21-day time range started at the day of catheterization. The block time will be at least 8 hours and depending on availability catheter may increase. 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 secret
public Maria Tavakoli Ardakani
Department of Clinical Pharmacy School of Pharmacy Shahid Beheshti University of Medical of Sciences Theran, Iran
Tehran Iran (Islamic Republic of) 14155-6153 +98 21 8820 0085 mariatavakoli@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Maria Tavkoli Ardakani
Shahid Beheshti University of Medical Sciences Tehran, Iran
Tehran Iran (Islamic Republic of) 14155-6153 +98 21 8820 0085 mariatavakoli@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) All of patients undergoing HSCT whom non-tunneled CVC (arrow) will be inserted newly. no limit no limit Both Hypersensivity to Vancomycin B95 Streptococcus, Staphylococcus, and Enterococcus as the cause of diseases classified elsewhere Treatment - Drugs Treatment - Drugs Intervention group (5 mg vancomycin, 2500 IU/ml heparin): Every night at a certain time, patients in the intervention group receive the block solution (vacomycin-heparin) . This block is done for each patient in a 21- day time interval from the day of catheterization. The block time is at least 8 hours but depending on catheter availability it may increase. When dwell time is over, researcher aspirates antibiotic lock solution from catheter lumen, flush catheter with 5ml normal saline before using line to administer medication.This process is done by the trained nurse. Lock solution is prepared based on it’s stability every 72 hour by pharmacist. Solution vancomycin-heparin stable 72 hours in room temperature based on Antibiotic Lock solution Therapy Guideline. Control group (Heparin only 100IU/ml base on routine program in ward): This block is done for each patient in a 21-day time range started at the day of catheterization. The block time will be at least 8 hours and depending on availability catheter may increase Fever, erythema, purulence (catheter exit site), swelling. Timepoint: observe for 21 days from catheterization. Method of measurement: clinical examination, thermometer. Infection. Timepoint: observe for 21 days from catheterization. Method of measurement: Blood culture (peripheral, catheter). WBC and Platelet engraftment. Timepoint: start of antibiotic lock until 21 days after. Method of measurement: CBC. Hospitalization time. Timepoint: from day of antibiotic lock until hospital clearance. Method of measurement: Day count. Shahid Beheshti University of Medical Sciences Approved 2019-02-19 Ethics committee of Shahid Beheshti University of Medical Sciences Department of Clinical Pharmacy, School of Pharmacy Shahid Beheshti University of Medical Sciences Tehran, IRAN Tehran Tehran Iran (Islamic Republic of)