Plain Language Summary
What is this summary about?
This is a plain language summary of an article originally published in the Clinical Journal of the American Society of Nephrology about the LOCK IT-100 study. The purpose of the LOCK IT-100 study was to find out if the taurolidine/ heparin catheter lock solution can help prevent catheter-related bloodstream infections, which can be serious or deadly, in patients with kidney disease who are receiving hemodialysis (blood dialysis) through a central venous catheter (CVC), which is a long, flexible tube made of medical-grade polyurethane or silicone that is inserted into a large vein. Hemodialysis refers to a process that eliminates waste products, toxins, and excess fluids from the blood when the kidneys do not work properly (kidney failure). Catheter lock solutions are put into the catheter in between dialysis sessions when the catheter is not in use. The solutions typically contain a blood thinner, such as heparin, to prevent blood clots from forming and blocking the catheter.
The taurolidine/heparin catheter lock solution, in addition to heparin, contains a unique antimicrobial drug to prevent bacteria and fungi from living in the catheter, where they may cause an infection by spreading to the bloodstream. These catheter‐related bloodstream infections are a deadly complication in some patients receiving hemodialysis through a catheter. The LOCK IT-100 study compared the taurolidine/heparin catheter lock solution with another catheter lock solution that contained heparin alone, which helped study researchers to find out if the taurolidine/heparin catheter lock solution was more effective in reducing the risk of these catheter-related bloodstream infections.
What were the key results?
Nine out of 397 (2%) people who received the taurolidine/heparin catheter lock solution developed a catheter‐related bloodstream infection compared with 32 out of 398 (8%) people who received the heparin catheter lock solution. The risk of developing a catheter-related bloodstream infection was reduced by 71% in people who received the taurolidine/heparin catheter lock solution compared with those who received heparin alone. Side effects were similar in the taurolidine/heparin and heparin groups. The most common serious side effects in both groups included pneumonia, fluid overload, and sepsis. Serious side effects are those that may have severe or life-threatening outcomes and may require hospitalization or medical treatment.
What do the results mean?
Patients receiving hemodialysis through a CVC were less likely to develop a catheter‐related bloodstream infection with the use of the taurolidine/heparin catheter lock solution than with the use of heparin alone. There were no safety concerns, meaning no potential harm or risk to participants in the study, related to the taurolidine/heparin catheter lock solution. These findings could help to inform patients with kidney disease and health care providers when making decisions about hemodialysis treatment.
Clinical trial number: NCT02651428
Acknowledgments
We gratefully thank the people who volunteered to participate in this study, their family members, and caregivers; the staff members at the study sites, nursing teams, and medical personnel who cared for them; the primary physician investigators at the study sites; and representatives of the sponsor who were involved in data collection and analyses.
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Disclosure statement
Anil K. Agarwal reports consultancy for CorMedix and Akebia; honoraria from Amgen; advisory or leadership roles for the American Society of Diagnostic and Interventional Nephrology (ASDIN), Clinical Nephrology, Frontiers in Nephrology, International Journal of Nephrology, International Society of Nephrology (ISN), Journal of Vascular Access, Kidney Self-Assessment Program, National Kidney Foundation (NKF), and The Open Urology & Nephrology Journal (all unpaid); advisor role to AstraZeneca and Otsuka; research support from Akebia; and other interests or relationships with ASDIN, American Society of Nephrology (ASN), ISN, and NKF. Jared Crandon reports employment with CorMedix Inc. Elizabeth Hurlburt reports employment with CorMedix Inc. Mary Michaud reports employment with CorMedix Inc. Antony Pfaffle reports employment with, ownership interest in, and advisory or leadership roles for CorMedix Inc.; and serves as Head of Patient Advocacy and Special Projects at CorMedix. Prabir Roy-Chaudhury reports employment with the University of North Carolina and Veterans Affairs Medical Center Salisbury; is a consultant/advisor for Akebia, Alexion, AstraZeneca, Bayer, Becton Dickinson, CorMedix, Humacyte, Medtronic, BMI OrganBank, Panoramic Science, Boston Scientific, and Vera; has ownership interest as Chief Scientific Officer and Founder of Inovasc LLC; receives National Institutes of Health Small Business Grants as multiple principal investigator or site principal investigator with Eko, Sojourn, and BioMed Organ Bank; receives research funding from Bayer; and has advisory or leadership roles for ASN, BMI OrganBank, and the editorial board of the Journal of Vascular Access. Celina Medina reports funding from CorMedix for speaker engagements. Paul T. Conway reports volunteer roles as Member, Board of Directors and Chair of Policy and Global Affairs of the American Association of Kidney Patients (AAKP) and Member, Board of Directors of the Rare Kidney Disease Foundation. Edward V. Hickey III reports volunteer roles as President, Board of Directors and Chair of the Veterans Health Initiative of the AAKP. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Medical writing and editorial support were provided by Kim Fuller, PhD, and Heather Nyce, PhD, of Lumanity Communications Inc., and were funded by CorMedix Inc.
Patient reviewers on this PLSP have received honorarium from Future Microbiology for their review work but have no other relevant financial relationships to disclose.
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Funding
This manuscript was funded by CorMedix Inc. The funders/sponsors were involved in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.