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IRCT20210317050735N1 IRCT 2023-01-04 Ardabil University of Medical Sciences Evaluation of the effect of Heparin alone and in combination with Vancomycin and Amikabisen in the prevention of tunnel catheter infection Comparative study of the effect of Heparin alone or in combination with Amikacin and Vancomycin antibiotics in the prevention of infection caused by tunnel central catheters in patients with renal insufficiency undergoing hemodialysis 2023-02-20 anticipated 60 Complete https://irct.ir/trial/55183 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Random numbers table is used for randomization. In order to use random numbers table, it will be determined first to read the numbers in the table, then the numbers are considered for different groups. We put our hands on one of the numbers and move in one of the predetermined directions and assign the numbers to different groups, Blinding description: The study will be blinded bilaterally. Patients will be blinded to the type of intervention and the researcher who must enter the data into the relevant checklist will be blinded to the type of intervention. 2 End stage renal disease. Intervention 1: Intervention group A: Patients undergoing hemodialysis who have recently had a tunneled central venous catheter installed will enter group A after obtaining consent. In this group, at the beginning of each dialysis session, 5000 units of heparin (manufactured by Caspin Pharmaceuticals) are injected into each lumen of the catheter, and the patients are evaluated for the occurrence of infection for six months. Intervention 2: Intervention group B: Patients undergoing hemodialysis who have recently had a tunneled central venous catheter installed will enter group B after obtaining consent. In this group, at the beginning of each dialysis session, 5 mg of vancomycin (manufactured by Dana Pharmaceuticals) and 5 mg of amikacin (manufactured by Caspin Pharmaceuticals) plus 5000 units of heparin are injected into each catheter lumen, and the patients are evaluated for the occurrence of infection for six months. Yes - There is a plan to make this available What will be shared: Individual data from study participants included demographic information, medical history, and evidence of catheter-related infection When: Access starts six months after the results are published To whom: Researchers working in academic and medical centers , physicians and medical students Conditions: For reference in conducting similar studies by mentioning the original source Where to obtain: Ardabil University of Medical Sciences, Vice Chancellor for Research or email Dr_maryam1983@gmail.com How to obtain: Contact by email or refer to the Vice Chancellor for Research of Ardabil University of Medical Sciences and make a request, full explanation of the purpose of having the data, provide a guarantee to mention the source Comments:
public Maryam Iranikia
No 26, Molavi st, Shahid hamzezadeh st, Hafez ave
Ardabil Iran (Islamic Republic of) 5615741715 +98 45 3373 2886 Dr.maryam.1983@gmail.com Ardabil University of Medical Sciences scientific Maryam Iranikia
No 26, Molavi st, Shahid hamzezadeh st, Hafez ave
Ardabil Iran (Islamic Republic of) 5615741715 +98 45 3373 2886 Dr.maryam.1983@gmail.com Ardabil University of Medical Sciences Iran (Islamic Republic of) Insertion of a new central tunnel catheter for hemodialysis Absence of inflammation in the vascular access area at the beginning of the study At least 2 months after starting dialysis Perform 2 or 3 dialysis sessions per week Being over 18 years old No specific diseases such as Leukemia, Infection, Immunodeficiency, Dermatitis 18 years no limit Both Having an infectious disease in other parts of the body Antibiotic use in the previous two weeks N18.6 End stage renal disease Treatment - Drugs Treatment - Drugs Intervention group A: Patients undergoing hemodialysis who have recently had a tunneled central venous catheter installed will enter group A after obtaining consent. In this group, at the beginning of each dialysis session, 5000 units of heparin (manufactured by Caspin Pharmaceuticals) are injected into each lumen of the catheter, and the patients are evaluated for the occurrence of infection for six months. Intervention group B: Patients undergoing hemodialysis who have recently had a tunneled central venous catheter installed will enter group B after obtaining consent. In this group, at the beginning of each dialysis session, 5 mg of vancomycin (manufactured by Dana Pharmaceuticals) and 5 mg of amikacin (manufactured by Caspin Pharmaceuticals) plus 5000 units of heparin are injected into each catheter lumen, and the patients are evaluated for the occurrence of infection for six months. Incidence of catheter-related infections in patients under hemodialysis. Timepoint: Six-month follow-up of the two groups. Method of measurement: Blood culture to evaluate for catheter-related infection. Fever. Timepoint: During the 6-month follow-up period. Method of measurement: fever measurement. Ardabil University of Medical Sciences Approved 2021-04-17 Ethics Committee of Ardabil University of Medical Sciences Fatemi hospital, Imam Khomeini street Ardabil Ardabil Iran (Islamic Republic of)