KiteLock™ Trial Targets Infections in Intestinal Failure

Cincinnati Children's is launching a groundbreaking clinical trial for KiteLock therapy that uses an FDA-designated “Breakthrough Device.” This is a promising treatment aimed at preventing central venous catheter (CVC) occlusions and infections in children with intestinal failure. Led by Paul Wales, MD, MSc, a renowned pediatric surgeon and surgical director of the Intestinal Rehabilitation Center at Cincinnati Children’s, and Samuel Kocoshis, MD, a leader in the field for nearly four decades and a historical medical director for the Intestinal Rehabilitation and Transplant programs, this trial represents a significant advancement in the management of pediatric intestinal failure.

The Need for Innovation in Intestinal Failure Management

Intestinal failure, often resulting from conditions like short bowel syndrome, poses severe challenges for pediatric patients. These children frequently rely on total parenteral nutrition (TPN) delivered through CVCs, which are prone to occlusions and infections. Historically, these complications have led to significant morbidity and even mortality, with liver disease and sepsis being common outcomes.

Wales has dedicated his career to improving outcomes for children with intestinal failure and emphasizes the critical need for innovative solutions.

"When I started my career, the mortality rate for these children was alarmingly high. Today, thanks to multidisciplinary care and advancements in treatment, we have significantly improved survival rates. However, the risk of CVC-related complications remains a major concern," he explains.

Introducing KiteLock Therapy

KiteLock therapy, developed by SterileCare Inc., utilizes a 4% tetrasodium EDTA solution to maintain patency through combined anticoagulant and antibiofilm properties. Unlike traditional heparin locks, KiteLock not only acts as an anticoagulant but also possesses antimicrobial properties, effectively disrupting biofilms that harbor bacteria and fungi that can lead to catheter obstruction and infection.

Wales' experience with KiteLock began at The Hospital for Sick Children in Toronto in 2016 after the availability of ethanol locks became uncertain and extremely costly. Wales, who was the director of the Intestinal Rehabilitation program at SickKids prior to relocating to Cincinnati Children’s in 2021, was the first to use KiteLock in children. The preliminary studies demonstrated its efficacy in reducing catheter-related complications.

"We found that KiteLock not only prevented infections but also maintained catheter patency better than ethanol locks, which were previously our go-to solution. Although infection is well controlled with ethanol locks, it is definitely associated with catheter occlusions in at least 15% of patients, which can require catheter replacement. In addition, ethanol lock is typically only used in silicone catheters as it can degrade the catheter material over time. We don’t have these concerns with KiteLock," he notes.

The Clinical Trial

The upcoming clinical trial, led by Cincinnati Children’s, seeks to validate these findings in a larger, controlled setting. The trial will involve pediatric patients with intestinal failure who are dependent on home TPN. Participants will be randomized to receive either KiteLock or heparin lock solutions over a 52-week period. The primary outcome will be the rate of catheter occlusions, with secondary outcomes including infection rates, safety and cost-effectiveness.

"This study is crucial for obtaining approval [from the Food and Drug Administration] for KiteLock in the United States,” says Wales. “Our goal is to provide a safer, more effective option for managing CVCs in these vulnerable patients. KiteLock is currently available for children in Canada, Europe and Australia, and we must get it for patients in the United States. The product appears to not only be more effective than ethanol lock, but also more cost effective."

Wales invites pediatric gastroenterologists and surgeons to consider referring eligible patients to this pivotal trial.

"We have eight sites participating in this study, and we are actively recruiting patients. By referring patients, you can play a vital role in advancing care for children with intestinal failure," Wales urges.

Beyond patient referrals, Wales encourages the medical community to advocate for the approval and adoption of innovative solutions like KiteLock.

"The impact of CVC complications extends beyond individual patients, affecting families and the healthcare system as a whole. By supporting this trial and similar initiatives, we can drive meaningful change in pediatric care," he says.

Cincinnati Children's continues to lead the way in pediatric intestinal failure research and treatment. The KiteLock Therapy clinical trial is a testament to our commitment to improving patient outcomes through innovation and collaboration.

Learn more about clinical trials at Cincinnati Children’s.