Antimicrobial Locks for Hemodialysis Catheter Infections

Oman Ministry of Health

Status and phase: Completed; Phase 2

Conditions: Vascular Access; Hemodialysis; Catheter Related Blood Stream Infection

Treatments: Drug: Taurolidine citrate 4% and heparin 500

Study type: Interventional

Funder types: Other

Identifiers

NCT07074821

MoH/CSR/24/27480

Details and patient eligibility

About

Tunneled hemodialysis catheters are susceptible to infection with high incidence of complication to the hemodialysis patients .The study aimed to prevent catheter infection through comparing use of antimicrobial solution (Taurolidine) when used as lock solution installed in the lumen of the catheter at the end of the hemodialysis session with the usually used lock solution heparin. The Study was performed on 100 hemodialysis patients over one year in Sohar hospital ,Oman .

Enrollment: 100 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All clinically stable adult end stage renal disease patients commence regular hemodialysis through tunneled hemodialysis catheter at Sohar hospital hemodialysis unit.

Exclusion criteria

• Patients with difficult vascular access and the tunneled hemodialysis catheter is the only functioning vascular access .
• Patients with poor flow from the catheter.
• Patients with active infection .
• Patients have displayed allergic reactions to either citrate or taurolidine.
• Patients were taking medication incompatible with either citrate or taurolidine

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Group (A) patients used usual Heparin used as tunneled hemodialysis lock solution

No Intervention group

Description:

Measure incidence of catheter related blood stream infection while patients use Heparin as catheter lock

Group (B) patients used Taurolidine based lock solution as tunneled hemodialysis catheter lock

Experimental group

Description:

Measure incidence of catheter related blood stream infection while patients use Taurolidine based lock solution as catheter lock

Treatment:

Drug: Taurolidine citrate 4% and heparin 500