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IRCT20241118063765N1 IRCT 2025-03-17 Qazvin University of Medical Sciences Comparative Evaluation of the Effects of Mupirocin Ointment and Chlorhexidine Versus Normal Saline in the Prevention of Dialysis-Related Infections Mupirocin Ointment and Chlorhexidine Gluconate Versus Normal Saline in the Prevention of Central Catheter Dialysis-Related Infections 2025-02-08 anticipated 120 Complete https://irct.ir/trial/81310 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Eligible individuals were assigned to study groups using balanced block randomization methods with a block size of six. A random sequence was generated using online random generator websites. 3 Central Catheter Dialysis-Related Infections. Intervention 1: Intervention group: In this group, 2% chlorhexidine in 70% alcohol will be administered to individuals. Following each dialysis session, prior to catheter insertion, this solution will be applied by the nurse to the patient. Intervention 2: Intervention group: In this group, mupirocin will be administered to individuals. Following each dialysis session, prior to catheter insertion, this medication will be administered by the nurse to the patient. Intervention 3: Control group: Individuals in this group will receive normal saline. Following each dialysis session, prior to catheter insertion, this solution will be administered by the nurse to the patient. Yes - There is a plan to make this available What will be shared: IPD collected for the primary outcome measure only When: Starting 6 months after publication To whom: This only available for people working in academic institutions or people working in businesses can also apply to receive it. Conditions: Researchers requiring access must submit formal requests outlining their intended use of the data, which will be reviewed by a data access committee or an institutional review board. Where to obtain: Individuals can submit their formal requests to the following email address: “amin.karampour@yahoo.com”. How to obtain: The process for requesting access to data or documents involves several key steps that require careful attention and adherence to established protocols. Initially, the applicant must prepare a formal request outlining the purpose of the data access, the specific information needed, and its intended use, which may take 1-2 weeks. Following submission, the request undergoes an initial review by the data access committee or institutional review board (IRB), lasting 1-3 weeks, before a thorough evaluation is conducted, which can take an additional 2-4 weeks. The applicant is then notified of the decision, typically within a week. Comments:
public Amin
Qazvin university of medical sciences., Bahona Blvd.
Qazvin Iran (Islamic Republic of) 34146388588 +98 28 1223 7267 amin.karampour@yahoo.com Qazvin University of Medical Sciences scientific Amin Karampour
Minoodar Blvd., Velayat Hospital., Qazvin City
Qazvin Iran (Islamic Republic of) 34146388588 +98 28 3333 6001 amin.karampour@yahoo.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Informed consent obtained Patients aged 18 years and older Patients on dialysis with a central venous catheter Ability and willingness to participate in the study and adhere to treatment protocols 18 years no limit Both Acute or chronic medical conditions that, in the opinion of the Principal Investigator (PI), may interfere with the assessment of the efficacy and/or safety of the study drug Patients who have not received antibiotic treatment for a proven catheter infection in the past month Patients who have not been treated with mupirocin or chlorhexidine in the past month Patients with a history of previous severe allergic reactions or known drug allergies to any of the study treatments Patients with a fistula or a temporary catheter (Shaldon catheter) Patients undergoing routine dialysis for end-stage renal disease (ESRD) who have been hospitalized for any reason T82.7 Infection and inflammatory reaction due to other cardiac and vascular devices, implants and grafts Prevention Prevention Placebo Intervention group: In this group, 2% chlorhexidine in 70% alcohol will be administered to individuals. Following each dialysis session, prior to catheter insertion, this solution will be applied by the nurse to the patient. Intervention group: In this group, mupirocin will be administered to individuals. Following each dialysis session, prior to catheter insertion, this medication will be administered by the nurse to the patient. Control group: Individuals in this group will receive normal saline. Following each dialysis session, prior to catheter insertion, this solution will be administered by the nurse to the patient. The rate of central venous catheter infection in dialysis patients. Timepoint: Measurement of infection rate in the second week, third week, fourth week, second month, third month, fourth month, fifth month, and sixth month. Method of measurement: Positive blood culture results and/or fever above 38 degrees Celsius, or hypothermia below 36.5 degrees Celsius during dialysis, and/or cellulitis (swelling, warmth, redness, or purulent discharge around the central catheter). Determining Length of Hospital Stay Due to Central Venous Catheter Infection in Three Groups. Timepoint: Second week, third week, fourth week, second month, third month, fourth month. Method of measurement: Patient Record. Determining Medication Consumption Behavior in Intervention and Control Groups. Timepoint: Checklist. Method of measurement: Second week, third week, fourth week, second month, third month, fourth month. The determination of changes in depression in two groups: intervention and control. Timepoint: Second week, third week, fourth week, second month, third month, fourth month. Method of measurement: Patient Health Questionnaire-2 (PHQ-2). The determination of changes in anxiety in two groups: intervention and control. Timepoint: Second week, third week, fourth week, second month, third month, fourth month. Method of measurement: Generalized Anxiety Disorder 2-item (GAD-2). Qazvin University of Medical Sciences Approved 2025-01-01 Ethics committee of Qazvin university of medical science Qazvin University of Medical Sciences, Shahid Bahonar Blvd. Qazvin Qazvin Iran (Islamic Republic of)