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Taurolidine/Heparin Lock Solution and Catheter-Related Bloodstream Infection in Hemodialysis: A Randomized,
Anil K Agarwal1, Prabir Roy-Chaudhury2,3, Phoebe Mounts4
1Department of Medicine, University of California San Francisco, Fresno, California.
Insights
The LOCK IT-100 trial found that taurolidine/heparin catheter lock solution significantly reduced catheter-related bloodstream infections (CRBSIs) in hemodialysis patients compared to heparin alone, with similar safety.
Area of Science:
- Nephrology
- Infectious Diseases
- Clinical Trials
Background:
- Catheter-related bloodstream infections (CRBSIs) are a major complication in hemodialysis patients with central venous catheters (CVCs).
- These infections lead to increased morbidity, mortality, and healthcare costs.
- Effective prevention strategies are crucial for improving patient outcomes.
Purpose of the Study:
- To compare the efficacy and safety of a taurolidine/heparin catheter lock solution against heparin alone in preventing CRBSIs.
- To evaluate the impact of the novel lock solution on catheter patency and removal rates.
Main Methods:
- A randomized, double-blind, active-control, multicenter phase 3 trial (LOCK IT-100) enrolled 795 adult hemodialysis patients with CVCs.
- Participants received either taurolidine/heparin or heparin catheter lock solution.
- The primary endpoint was time to CRBSI, with secondary endpoints including catheter removal and patency.
Main Results:
- Taurolidine/heparin significantly reduced CRBSI risk by 71% compared to heparin (0.13 vs. 0.46 events per 1000 catheter days; P < 0.001).
- The study was terminated early for efficacy, with no significant safety concerns identified.
- No differences were observed in catheter removal or patency rates between the groups.
Conclusions:
- Taurolidine/heparin catheter lock solution is effective in preventing CRBSIs in hemodialysis patients.
- The solution demonstrates a comparable safety profile to heparin.
- This represents a significant advancement in managing CVC complications during hemodialysis.
Background:
Catheter-related bloodstream infections (CRBSIs) are one of the most prevalent, fatal, and costly complications of hemodialysis with a central venous catheter (CVC). The LOCK IT-100 trial compared the efficacy and safety of a taurolidine/heparin catheter lock solution that combines taurolidine 13.5 mg/ml and heparin (1000 units/ml) versus heparin in preventing CRBSIs in participants receiving hemodialysis via CVC.
Methods:
LOCK IT-100 was a randomized, double-blind, active-control, multicenter, phase 3 study that enrolled adults with kidney failure undergoing maintenance hemodialysis via CVC from 70 US sites. Participants were randomized 1:1 to taurolidine/heparin catheter lock solution or heparin control catheter lock solution (1000 units/ml). The primary end point was time to CRBSI as assessed by a blinded Clinical Adjudication Committee. Secondary end points were catheter removal for any reason and loss of catheter patency. On the basis of a prespecified interim analysis, the Data and Safety Monitoring Board recommended terminating the trial early for efficacy with no safety concerns.
Results:
In the full analysis population ( N =795), nine participants in the taurolidine/heparin arm ( n =397; 2%) and 32 participants in the heparin arm ( n =398; 8%) had a CRBSI. Event rates per 1000 catheter days were 0.13 and 0.46, respectively, with the difference in time to CRBSI being statistically significant, favoring taurolidine/heparin ( P < 0.001). The hazard ratio was 0.29 (95% confidence interval, 0.14 to 0.62), corresponding to a 71% reduction in risk of CRBSIs with taurolidine/heparin versus heparin. There were no significant differences between study arms in time to catheter removal for any reason or loss of catheter patency. The safety of taurolidine/heparin was comparable with that of heparin, and most treatment-emergent adverse events were mild or moderate.
Conclusions:
Taurolidine/heparin reduced the risk of developing a CRBSI in study participants receiving hemodialysis via CVC compared with heparin with a comparable safety profile.
Clinical Trial Registry Name And Registration Number:
Study Assessing Safety & Effectiveness of a Catheter Lock Solution in Dialysis Patients to Prevent Bloodstream Infection, NCT02651428 .
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