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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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250503065575N1
Enrollment
276
Registered
2025-10-07
Start date
2025-10-23
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Catheter infections in patients undergoing dialysis. Condition 2: End stage renal disease. Condition 3: Dependence on renal dialysis. 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

Interventions

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

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Dialysis patients aged 18 to 80 years Catheterization >14 days or prior catheter removal >3 months before trial enrollment. Hemodialysis > 2 sessions/ week

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Incidence of Catheter-Related Bloodstream Infections (CRBSIs). Timepoint: Every 14 days. Method of measurement: Blood culture and laboratory parameters.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public Contactkosar ojaghi

Shahid Beheshti University of Medical Sciences

kosarojaghi@sbmu.ac.ir+98 21 7343 3000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026