Clinical Research Directory

Open-Label Study to Assess Safety and Time to Catheter-related Bloodstream Infections (CRBSI) in Subjects From Birth to < 18 Years of Age

This study is a post-marketing approval requirement to assess the safety and time to Catheter-related Bloodstream Infections (CRBSI) of DefenCath in pediatric population (birth to less than 18 years of age) who are on chronic HD for kidney failure.

Effectiveness of the NowCath Foley in Reducing Catheter-Associated UTIs and Blockages in Long-Term Indwelling Catheter Users (REDUCE)

People who rely on long-term indwelling urinary (Foley) catheters often experience recurrent urinary tract infections and catheter blockages that require unscheduled catheter changes, additional antibiotics, and emergency visits. These complications reduce quality of life and increase healthcare use. The NowCath Foley is an all-silicone indwelling urinary catheter with two additional drainage eyelets positioned below the retention balloon. A thin silicone skirt covers the eyelets to reduce suction against the bladder wall. The design is intended to improve bladder emptying and reduce mucosal contact, which may in turn lower the rate of catheter-associated urinary tract infections (CAUTIs) and blockages compared with a conventional all-silicone Foley catheter. The REDUCE study is a multi-centre, randomized, blinded, controlled crossover clinical investigation conducted in Denmark. The primary goal is to determine whether the NowCath Foley catheter can reduce incidence of CAUTI over 12 weeks compared to a conventional long-term indwelling Foley catheter in an adult population using indwelling urethral or suprapubic Foley catheters . The participants (n=160) are cared for and enrolled by community nursing services in the Ikast-Brande and Holstebro municipalities in collaboration with the coordinating site at Regional Hospital Gødstrup. Each participant will use both the NowCath Foley and a conventional all-silicone Foley catheter (Rüsch Brillant, Teleflex Medical) in a randomized sequence, for 12 weeks each (24 weeks total). The primary outcome is the rate of catheter changes per 100 catheter days. Secondary outcomes include CAUTI incidence, blockage incidence, residual urine volume, encrustation, antibiotic use, quality of life, patient comfort, safety, and cost-effectiveness. During phase 1, participants will be randomised to either NowCath or the conventional Foley catheter and will be seen at weeks 0 and 12. At week 12 participants will be crossed-over to phase 2, where they will receive the other catheter not allocated in phase 1 and will be seen at weeks 12 and 24. As the participants would default to the comparator catheter as part of standard of care, the wash-out period is minimal.

Efficacy and Safety of Peripherally Inserted Central Venous Catheters

Central venous access is critical for administering intravenous medications, parenteral nutrition, and fluid therapy in intensive care units (ICUs). Peripherally inserted central catheters (PICCs) provide an alternative to traditional centrally placed catheters, but they can be associated with complications such as blood clots (thrombosis), catheter-related infections, and mechanical blockages. The primary purpose of this study is to assess the procedural efficacy, functional lifespan, and complication rates of ultrasound-guided PICCs in critically ill adult patients. In this prospective observational study, 60 adult ICU patients who require central venous access for at least 5 to 7 days will undergo bedside PICC placement by radiology staff using real-time ultrasound guidance and the modified Seldinger technique. Proper positioning of the catheter tip will be verified by a portable chest radiograph immediately after insertion. Participants will be monitored daily while the catheter remains in place until line removal, ICU discharge, or death. Surveillance includes daily clinical site inspections, structured laboratory assessments, and scheduled compression Doppler ultrasound scans to check for blood clots in the cannulated arm. If an infection or blockage is suspected, appropriate blood cultures and diagnostic work-ups will be conducted. The gathered data will determine the insertion success rate, functional patency rate, and the overall incidence of complications per 1,000 catheter-days to establish evidence-based guidelines for vascular access in critical care.

Secondary Prevention of VTE in Patients With Cancer and Catheter-Related Upper Extremity Deep Vein Thrombosis

This trial seeks to evaluate a management strategy after the acute treatment duration (≥ 3 months of therapeutic anticoagulation) for patients with cancer and catheter-related upper extremity deep vein thrombosis (DVT).

A Study of the IJV or the SCV Approach for Ultrasound-guided Implantation of TIVAD

To compare IJV and SCV as the implantation site of TIVAD and its associated thrombotic or occlusion rate, our study plans to enroll 240 patients with cancer who require central line TIVADs and randomizes them with 1:1 ratio to receive the TIVAD implantation at SCV or IJV. After the implantation, the patients will be regularly followed through phone contact and chart review for 2 years, and any symptomatic thrombosis or occlusion will be found during chemotherapy injection or regular push-pull heparin saline flush every 6 weeks as our hospital care protocol. To detect any asymptomatic thrombosis, the patients will also receive screening vascular ultrasound at 2 weeks, 2 months, and 6 months postoperatively. The study primary endpoints include any infection, asymptomatic thrombosis found by screen ultrasound, and clinically symptomatic thrombosis or occlusion and major mechanical failure/dislocation of TIVAD.

Advanced Dressings for CVC Infection Prevention in PICU

Randomised, single-blind clinical trial comparing chlorhexidine gluconate-impregnated transparent dressings versus conventional transparent dressings in the prevention of central venous catheter-related bloodstream infections (CVC-BSI) in paediatric patients admitted to a tertiary hospital PICU. Outcomes include incidence of BRCVC, catheter colonisation, dressing-related skin complications, and number of dressing changes.

ATAPAC Study (TauroLock Activity in Adult Cancer Patients)

The purpose of this study is to compare the efficacy of a lock taurolidine-citrate solution vs standard saline solution for primary prevention of central venous catheter-associated bloodstream infection in adult patients treated with intra-venous therapy for a solid tumor

Hemodialysis Catheter Complications in the Emergency Department Versus Hemodialysis Unit

This prospective observational cohort study was designed to compare the risk of catheter thrombosis and catheter-related infection between adult patients who underwent temporary hemodialysis catheter insertion in the emergency department and those who underwent catheter insertion in the hemodialysis unit. The study was conducted at Antalya Training and Research Hospital. Adult patients aged 18 years and older who underwent hemodialysis catheter insertion in either the emergency department or the nephrology hemodialysis unit were included. A total of 398 patients were enrolled between December 1, 2024, and December 1, 2025. Demographic and clinical data were collected, and catheter-related complications occurring within 10 days after catheter insertion were assessed using hospital records and follow-up data.

Treatment and Prevention of Catheter Related Urinary Tract Infection Use D-mannose

Purpose of study To find out whether D-mannose use can prevent urinary tract infection in patients need long-term catheterization.

Novel Antimicrobial Dressing in Peripheral Intravenous Catheters (PIVCs)

The goal of this clinical trial is to compare a chlorhexidine impregnated dressing for peripheral intravenous catheters (PIVCs) to the standard dressing currently used in general medical and surgical inpatient wards. The main questions it aims to answer are: * Study Feasibility * Occurrence of infectious complications related to the PIVC Participants will be randomly allocated to receive either of the below dressings to cover and secure their PIVC: * The standard dressing used at their hospital, or * The intervention dressing which has Chlorhexidine gluconate (CHG) on it Researchers will compare standard and CHG dressings to see if the presence of CHG improves the occurrence of infectious complications related to the PIVC.

Chlorhexidine Caps for CLABSI Prevention in Hemodialysis: a Pilot Randomized Controlled Trial

The goal of this clinical trial is to compare a chlorhexidine antimicrobial barrier cap in patients requiring hemodialysis treatment to the standard hemodialysis caps currently used within the Metro North Kidney Health Service. The main questions to answer are: * Study Feasibility * Occurrence of infectious complications related to renal central venous catheters Participants will be randomly allocated to receive either of the below hemodialysis caps to cover their hemodialysis catheter hub: * The standard hemodialysis cap used at the Royal Brisbane and Women's Hospital, or * The intervention hemodialysis cap containing chlorhexidine inside it Researchers will compare standard and chlorhexidine hemodialysis caps to see if the presence of chlorhexidine improves the occurrance of infectious complications related to the hemodialysis catheter.

Biofilm-induced Antimicrobial Resistance RIsk ERadication in Critical Care Central Venous Catheters

Central venous catheter (CVC) infections are a frequent and serious nosocomial complication in critical care, leading to increased morbidity, mortality, and costs. The pathophysiology of these infections relies on the formation of a biofilm, an organized microbial structure that confers exceptional tolerance to anti-infectives and the immune system. However, data concerning the characteristics of the in vivo biofilm (kinetics, composition, endo- vs. extraluminal organization) on central venous catheters in intensive care patients are very limited, hindering the development of effective and targeted prevention strategies. The main aim of this study is to quantify the density and describe the spatial distribution (extra- and intraluminal compartments) of the biofilm on infected or colonized central venous catheters, prospectively collected from patients in the critical care units.

Analysis of Microbial Biofilms in Peripheral Venous Catheters and Their Implication in Infectious Risk

Peripheral venous catheters (PVCs) are the most commonly used intravascular medical devices in healthcare establishments. Although essential in patient care, PVCs represent a significant risk factor for nosocomial infections, as shown by the results of the national prevalence survey. While the main pathophysiological mechanisms are known, the specific factors driving the transition from simple colonization to infection remain unclear. This project aims to identify the major factors involved in the occurrence of bacterial infections related to the colonization of peripheral venous catheters.

Digital Transformation of Continuity of Care for Peripherally Inserted Central Catheters: SpadCare Experience

The study focuses on patients who require outpatient infusion of therapy ("Infusions, Intravenous"\[Mesh\]) "Administration, Intravenous"\[Mesh\] ("Home Infusion Therapy"\[Mesh\]) "Parenteral Nutrition, Home"\[Mesh\] via a peripherally inserted central catheter (PICC) ("Central Venous Catheters"\[MeSH\] "Catheterization, Central Venous"\[MeSH\] "Catheterization, Peripheral" \[MeSH\] "Vascular Access Devices"\[Mesh\] )