Catheter Caps for Dialysis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new device called the Catheter Caps Case (C3) to assess its comfort and ease of use for dialysis patients. It targets individuals with a hemodialysis catheter undergoing regular dialysis. Those with a tunneled dialysis catheter that will not be removed soon and without acute kidney issues might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to the development of innovative solutions for dialysis care.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that this device is safe for dialysis patients?
Research shows that the Catheter Caps Case (C3) aims to make dialysis more comfortable for patients. Although detailed safety information from past studies is lacking, this trial is marked as "Not Applicable" in phase, indicating that the main goal isn't to test safety as in early drug trials. This suggests the device is likely low-risk.
Since the focus is on a device, not a drug, safety concerns may differ. If C3 resembles other caps used in dialysis, such as those designed to fight germs, they are usually well-tolerated by patients. These caps help prevent infections at the catheter insertion site, a common issue in dialysis. Overall, despite the absence of specific safety data for C3, the trial's nature and the performance of similar devices suggest it should be safe to use.12345Why are researchers excited about this trial?
Researchers are excited about the Catheter Caps Case (C3) because it offers a potentially safer and more effective way to prevent infections for patients undergoing dialysis. Unlike traditional catheter caps, which can sometimes fall short in preventing bacterial contamination, C3 is designed with an innovative sealing mechanism that enhances its antimicrobial protection. This new approach could significantly reduce the risk of infections, which is a major concern for patients with dialysis catheters. By improving safety and potentially reducing complications, C3 could lead to better patient outcomes and a higher quality of life for those relying on dialysis.
What evidence suggests that the Catheter Caps Case (C3) is effective for dialysis patients?
Research has shown that catheter caps coated with chlorhexidine greatly reduce infections in dialysis patients. Studies have found that these caps lower the risk of bloodstream infections, which are common in patients with central venous catheters. Chlorhexidine, an antiseptic, helps keep the catheter area clean and reduces germs. Patients report that these caps are more comfortable and easier to use than traditional methods. These findings suggest that the Catheter Caps Case (C3) could make dialysis safer and more comfortable.12678
Are You a Good Fit for This Trial?
This trial is for dialysis patients who use a hemodialysis catheter. It's designed to assess how comfortable and easy it is to use a new device called Catheter Caps Case (C3) over a short period.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use the Catheter Caps Case (C3) attached to the hemodialysis catheter for evaluation over a 15-minute period
Follow-up
Participants are monitored for any immediate reactions or issues following the use of the Catheter Caps Case
What Are the Treatments Tested in This Trial?
Interventions
- Catheter Caps Case (C3)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor