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

Comparative Efficacy of Taurolidine, 30% Citrate, 4% Citrate, and Heparin Lock Solutions in Preventing Catheter-Related Infections in Hemodialysis Patients with Central Venous Catheters

A phase 3 randomized (using a number table) double-blind trial allocated 276 patients into three intervention groups and one control group.

Patients will be divided into four groups: three intervention groups receiving taurolidine, 4% citrate, or 30% citrate lock solutions, and a control group receiving heparin according to the standard protocol of Imam Hossein, Qaem, Shohada Ghamnam, and Shariati hospitals. Lock solutions will be administered immediately after each dialysis session, with blood samples collected every 14 days for culture, CBC, differential, CRP, and procalcitonin. All patients will be followed for three months.

Inclusion Criteria: • 18<age<80 .Hemodialysis >2 sessions/week. . Catheterization >3 months or prior catheter removal >12 months before trial enrollment. Exclusion Criteria: • Use of systemic antibiotics within 14 days prior to enrollment • catheter-site infection • ]mmunodeficiency • Pregnancy or lactation • Allergy to citrate, heparin, or taurolidine • History of seizures

Patients were randomized into four groups (n=69 each). Three intervention groups received taurolidine, 4% citrate, or 30% citrate lock solutions, while the control group received heparin according to hospital protocol. The assigned lock solution was administered after each dialysis session.

Incidence of catheter-related bloodstream infections (CRBSI), Number of catheter-related infections per group, Catheter patency and survival, Adverse events related to lock solutions, Laboratory parameter changes, Frequency of catheter replacements, Occurrence of systemic or secondary infections.

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.

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.