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IRCT20250503065575N1 IRCT 2025-10-07 Shahid Beheshti University of Medical Sciences An evaluation of the effectiveness of taurolidine, 30% citrate, 4% citrate, and heparin as lock solutions in preventing infections among patients with end-stage renal disease (ESRD) requiring dialysis An evaluation of the effectiveness of taurolidine, 30% citrate, 4% citrate, and heparin as lock solutions in preventing infections among patients with end-stage renal disease (ESRD) requiring dialysis 2025-10-23 anticipated 276 Recruiting https://irct.ir/trial/86288 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Participants will first be selected according to the study’s inclusion and exclusion criteria. Following the provision of informed consent, individuals will be randomly allocated to either the intervention or control group using appropriate randomization methods (e.g., random number tables). This randomization aims to ensure a balanced distribution of both known and unknown confounding factors across groups, with each participant having an equal probability of assignment to either arm. In this study, group allocation will be managed by an independent individual, not involved in the research team, to minimize selection and allocation bias. For this purpose, a sufficient number of sealed, opaque envelopes will be prepared for the intervention and control groups, with the assigned group (intervention or control) concealed inside each envelope. Data will be collected and analyzed without knowledge of group assignments. Whenever feasible, the intervention and placebo will be designed to have an identical appearance, and both participants and outcome assessors will remain blinded to group allocation (double-blind design). Upon completion of data collection, the allocation code will be unsealed, Blinding description: In a double-blind study, blinding the patient involves preparing the active treatment and placebo to look, smell, and be administered in exactly the same way, so the patient cannot distinguish between them. To blind the healthcare staff, treatment packages are labeled with codes or identification numbers, and only an independent party (such as a pharmacist or randomization officer) who is not involved in the trial has access to the group assignments. Researchers and outcome assessors also work with coded data and remain unaware of the actual group allocations until the data collection is complete. This process prevents both conscious and unconscious influence on treatment administration or outcome evaluation, ensuring the scientific validity of the study. 3 Condition 1: Catheter infections in patients undergoing dialysis. Condition 2: End stage renal disease. Condition 3: Dependence on renal dialysis. Intervention 1: Control group: Heparin at a concentration of 1,000–5,000 units/mL will be instilled into the catheter lumen as a lock solution after each hemodialysis session. This regimen represents the standard practice routinely employed in the hospital. Intervention 2: first Intervention group: Taurolidine will be instilled into the catheter lumen as a lock solution after each hemodialysis session, in a volume corresponding to the internal volume of the lumen. Intervention 3: second Intervention group: citrate 4% will be instilled into the catheter lumen as a lock solution after each hemodialysis session, in a volume corresponding to the internal volume of the lumen. Intervention 4: Intervention group: Citrate 30% will be instilled into the catheter lumen as a lock solution after each hemodialysis session, in a volume corresponding to the internal volume of the lumen. 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 further information.
public kosar ojaghi
Imam hossein hospital, Shahid madani st., Imam hossein sq.
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 3000 kosarojaghi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Kosar Ojaghi
Shahid Madani st, Imam hossein hospital, Tehran
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 3000 kosarojaghi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Dialysis patients aged 18 to 80 years Catheterization >14 days or prior catheter removal >3 months before trial enrollment. Hemodialysis > 2 sessions/ week 18 years 80 years Both Antibiotic use within 14 days prior to enrollment. Active infection at the site of the catheter Immunodeficiency pregnant woman Breastfeeding Allergy to Citrate, Heparin and Taurolidine History of seizure Any disease with vasculopathy T82.7 N18.6 T82.7 Infection and inflammatory reaction due to other cardiac and vascular devices, implants and grafts End stage renal disease Infection and inflammatory reaction due to other cardiac and vascular devices, implants and grafts Prevention Prevention Prevention Prevention Control group: Heparin at a concentration of 1,000–5,000 units/mL will be instilled into the catheter lumen as a lock solution after each hemodialysis session. This regimen represents the standard practice routinely employed in the hospital. first Intervention group: Taurolidine will be instilled into the catheter lumen as a lock solution after each hemodialysis session, in a volume corresponding to the internal volume of the lumen. second Intervention group: citrate 4% will be instilled into the catheter lumen as a lock solution after each hemodialysis session, in a volume corresponding to the internal volume of the lumen. Intervention group: Citrate 30% will be instilled into the catheter lumen as a lock solution after each hemodialysis session, in a volume corresponding to the internal volume of the lumen. Incidence of Catheter-Related Bloodstream Infections (CRBSIs). Timepoint: Every 14 days. Method of measurement: Blood culture and laboratory parameters. White blood cell. Timepoint: Every 14 days. Method of measurement: Blood sample. Temprature. Timepoint: Every 14 days. Method of measurement: Thermometer. Heart rate. Timepoint: Every 14 days. Method of measurement: Heart monitoring. C-reactive protein. Timepoint: Every 14 days. Method of measurement: Blood sample. Procalcitonin. Timepoint: Every 14 days. Method of measurement: Blood sample. Shahid Beheshti University of Medical Sciences Approved 2025-04-29 Ethics committee of Shahid beheshti medical science university Shahid Beheshti medical science university, Daneshjoo blvd Tehran Tehran Iran (Islamic Republic of)