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IRCT20210811052145N1 IRCT 2021-09-29 Bandare-abbas University of Medical Sciences Comparison of the effectiveness of cefazolin-heparin lock therapy and ethanol-heparin lock therapy on the persistence and site infection in hemodialysis catheter patients Comparison of the effectiveness of cefazolin-heparin lock therapy and ethanol-heparin lock therapy on the persistence and site infection in hemodialysis catheter patients 2021-04-04 anticipated 80 Complete https://irct.ir/trial/58037 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, a simple and individual random method was used. In this way, based on the sample size of the study and using the table of random number allocation, 80 codes from number one to eighty were assigned to patients (Randomized Allocation). Then the patients were randomly assigned to two intervention groups. ELT (Ethanol lock therapy) expression was considered for ethanol block group and ALT(Antibiotic lock therapy) expression was considered for cefazolin block group. Finally, after the researcher referred to the hemodialysis center, the eligible patients were assigned to two intervention groups based on the order of randomized codes, Blinding description: In this study, nurses and statistical analysts are unaware of the type of block and groups. N/A catheters site infection in hemodialysis pationts. Intervention 1: ethanol-heparin block group: In the ethanol-heparin block group, participants received routine and standardized care after the end of the hemodialysis process, which included rinsing the catheter lumens with normal saline. Finally, the ethanol-heparin block solution with a ratio of 2 (ethanol) to 1 (heparin) was blocked by a research colleague according to the volume of catheter lumens. It should be noted that the volume of the catheter lumens is about 3CC. The solution remains in the catheter until the next visit. At the next visit before hemodialysis, first evaluate the patient, including weight control and blood pressure by the researcher and complete the checklist for catheter infection according to the CDC criteria, which includes redness, tenderness, hardening of the catheter tissue about 2 cm, presence Or the absence of fever was done by the researcher and the ward manager. The blocked solution is then aspirated and hemodialysis is started. Intervention 2: cefazolin lock group: In the cephazolin-heparin block group, after the end of the hemodialysis process, they received routine and standard care, which included rinsing the catheter lumens with normal saline, then cefazolin-heparin block solution with a ratio of 2 (cefazolin) to 1 (heparin). Was ready, Due to the lumen volume, the catheter was blocked by a research colleague. It should be noted that the volume of the catheter lumens is about 3CC. The solution remains in the catheter until the next visit. At the next visit before hemodialysis, the patient first evaluates the patient, including weight control and blood pressure, and completes a checklist for catheter infection according to the CDC criteria, which includes redness, tenderness, and hard The tissue of the catheter site is about 2 cm, the presence or absence of fever, was done by the researcher and the ward manager. Then the blocked solution is aspirated and hemodialysis is started. The solution remains in the catheter until the next visit. At the next visit before hemodialysis, first evaluate the patient, including weight control and blood pressure by the researcher and complete the checklist for catheter infection according to the CDC criteria, which includes redness, tenderness, hardening of the catheter tissue about 2 cm, presence Or the absence of fever was done by the researcher and the ward manager. The blocked solution is then aspirated and hemodialysis is started. 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 Due to the privacy of the participants
public Seyed Mehdi Hosseinifard
No.14, 28Ave., Fadaeian Blvd., Farrokhshahr Town
Farrokhshahr Iran (Islamic Republic of) 8831855659 +98 38 3242 9362 mehdi.hosseinifard@yahoo.com Bandare-abbas University of Medical Sciences scientific Dr.Hadi Yousefi
Imam Hussain Boulevard
Bandar Abbas Iran (Islamic Republic of) 7916613885 +98 76 3334 4429 hadiyousefi17@gmail.com Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Informed consent Referral and introduction of the patient by the physician over 18 years old 18 years no limit Both Lack of willingness to participate use of systemic antibiotics Use of immunosuppressive drugs Having a previous catheter or systemic infection Prevention Prevention ethanol-heparin block group: In the ethanol-heparin block group, participants received routine and standardized care after the end of the hemodialysis process, which included rinsing the catheter lumens with normal saline. Finally, the ethanol-heparin block solution with a ratio of 2 (ethanol) to 1 (heparin) was blocked by a research colleague according to the volume of catheter lumens. It should be noted that the volume of the catheter lumens is about 3CC. The solution remains in the catheter until the next visit. At the next visit before hemodialysis, first evaluate the patient, including weight control and blood pressure by the researcher and complete the checklist for catheter infection according to the CDC criteria, which includes redness, tenderness, hardening of the catheter tissue about 2 cm, presence Or the absence of fever was done by the researcher and the ward manager. The blocked solution is then aspirated and hemodialysis is started. cefazolin lock group: In the cephazolin-heparin block group, after the end of the hemodialysis process, they received routine and standard care, which included rinsing the catheter lumens with normal saline, then cefazolin-heparin block solution with a ratio of 2 (cefazolin) to 1 (heparin). Was ready, Due to the lumen volume, the catheter was blocked by a research colleague. It should be noted that the volume of the catheter lumens is about 3CC. The solution remains in the catheter until the next visit. At the next visit before hemodialysis, the patient first evaluates the patient, including weight control and blood pressure, and completes a checklist for catheter infection according to the CDC criteria, which includes redness, tenderness, and hard The tissue of the catheter site is about 2 cm, the presence or absence of fever, was done by the researcher and the ward manager. Then the blocked solution is aspirated and hemodialysis is started. The solution remains in the catheter until the next visit. At the next visit before hemodialysis, first evaluate the patient, including weight control and blood pressure by the researcher and complete the checklist for catheter infection according to the CDC criteria, which includes redness, tenderness, hardening of the catheter tissue about 2 cm, presence Or the absence of fever was done by the researcher and the ward manager. The blocked solution is then aspirated and hemodialysis is started. Prevention of catheter site infection. Timepoint: daily. Method of measurement: Redness - Sensitivity to touch - Hardening of catheter tissue about 2 cm - No fever or fever. Increased catheter durability. Timepoint: daily. Method of measurement: From the time the catheter is inserted until the onset of symptoms of infection. researcher Approved 2019-05-29 Ethics comittee of hormozgan University of Medical Sciences Islamic Republic of Iran Blvd, shahid mohammadi hospital Bandar abbas Hormozgan Iran (Islamic Republic of)