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NCT01293799
BACKGROUND: Peritonitis remains a significant problem in peritoneal dialysis (PD). It is the leading cause of technique failure, and contributes to mortality. The incidence is highest during the first year of treatment. Non-compliance with the PD protocol is shown to be an important risk factor for peritonitis. Reinforcement of knowledge and ability to perform PD therefore appears to be a possible way to reduce the incidence of peritonitis. This will be studied in The PEritonitis Prevention Study (PEPS). METHODS: The objective of this randomized, multi-centre investigation, which will include 750 new PD patients who can perform (PD) without assistance, is to evaluate if regular retraining can reduce the incidence of peritonitis, the technique-failure rate, and the hospitalisation days due to peritonitis compared with regular follow-up regimen. Patients in the intervention group will be tested by a PD-technique test and a questionnaire at regular intervals after PD-start and after every peritonitis episode with focus on infection prophylaxis. If needed, they will be retrained. The control group will be treated according to the routine of the center. The study is ongoing in Denmark, Norway, Sweden, Finland, Estonia, Latvia, the Netherlands, and the United Kingdom (UK). The study will go on for 6 years.
NCT07113587
This study aims to investigate the pharmacokinetics (PK) and pharmacodynamic (PD) profiles of four commonly used antibiotics - meropenem, ampicillin, aztreonam, and ciprofloxacin - administered via intravenous (i.v.) and intraperitoneal (i.p.) routes in patients undergoing automated peritoneal dialysis (APD) without peritonitis. Existing dosing regimens for APD patients are often extrapolated from continuous ambulatory peritoneal dialysis (CAPD) data, despite notable differences in dialysis dynamics, solute clearance, and drug disposition between the two modalities. This discrepancy may result in subtherapeutic exposure or overtreatment, leading to poor clinical outcomes or drug toxicity. Automated peritoneal dialysis is characterized by multiple, frequent short cycles of dialysate exchange during the night, along with a prolonged daytime dwell using icodextrin-based solutions. These unique features influence both the systemic absorption and elimination of intraperitoneally administered antibiotics. The pharmacokinetics of these antibiotics in APD patients, particularly with regard to intermittent i.p. dosing, remains insufficiently studied. This single-center, open-label, randomized crossover study will evaluate plasma, dialysate, and urine concentrations of each antibiotic after both i.v. and i.p. administration in 24 adult patients (6 per drug group) receiving APD. Each subject will receive a single dose of one antibiotic (either 0.5g meropenem, 2g ampicillin, 1g aztreonam, or 400mg ciprofloxacin) via both routes, separated by a one-week washout period. Intraperitoneal administration will occur at the end of the cycler session, allowing the drug to dwell in 1.5L of icodextrin solution during the long daytime exchange. Serial samples of plasma, peritoneal dialysate, and urine will be collected over a 24-hour period following each drug administration. High-performance liquid chromatography (HPLC) will be used to measure drug concentrations. Pharmacokinetic parameters to be calculated include area under the concentration-time curve (AUC), maximum concentration (Cmax), half-life (t½), and time to maximum concentration (Tmax). Secondary PK/PD indices such as time above the minimum inhibitory concentration (T\>MIC) and AUC/MIC ratios will also be assessed to estimate the potential efficacy at the infection site. The study drugs have well-characterized safety profiles and have been previously used via both i.v. and i.p. routes in CAPD and clinical practice. The study protocol includes safety monitoring, including assessment of adverse events, vital signs, hematology, and clinical chemistry parameters. Risks to subjects are considered minimal, primarily related to venous catheterization and single-dose drug administration. Participants are not expected to receive direct therapeutic benefit but will contribute to the optimization of antimicrobial therapy in APD patients with infections such as peritonitis and pneumonia. This research addresses a critical gap in evidence-based dosing of antimicrobials in the APD population. Results from this study may inform future clinical guidelines and support rational selection and dosing of antibiotics in peritoneal dialysis-associated infections. It also offers insight into the feasibility of intermittent intraperitoneal therapy in APD patients and the systemic exposure achieved through this route. The study is conducted in accordance with Good Clinical Practice (GCP), the Declaration of Helsinki, and Austrian regulatory and ethical requirements.
NCT05860270
This is a multicenter randomized, placebo-controlled trial of Vitamin D supplementation in patients on peritoneal dialysis to determine whether oral administration of vitamin D3 after curing an episode of peritonitis could reduce the risk of subsequent peritoneal dialysis-related peritonitis.
NCT05971537
Biofilm formation is an important cause of catheter-related infection. In hemodialysis, use of an antibiotic-lock has been proven to be effective to manage such a complication with preservation of the central venous catheter. In peritoneal dialysis, while biofilm has been implicated in relapsing and repeat peritonitis, both of which are caused by the identical bacteria as in their preceding peritonitis episode, no adjunctive measure has been proven to be effective to eradicate the biofilm bacteria. As a result, Tenckhoff catheter removal is the only recommended option for the patients suffering from relapsing or repeat peritonitis. In this study, the investigators are going to investigate whether the use of an antibiotic-lock can be useful to eradicate the biofilm in the Tenckhoff catheter to prevent future episodes of peritonitis caused by the same organism.
NCT05285436
This study aims to determine if the CloudCath device can detect infections related to peritoneal dialysis (peritonitis) as fast or faster than the current standard methods used by patients and doctors to detect such infections.
NCT05300191
A proof-of-concept study of a prototype CloudCath device designed to detect peritonitis using the effluent dialysate from patients undergoing peritoneal dialysis.
NCT04515498
This study aims to determine if the CloudCath device can detect infections related to peritoneal dialysis (peritonitis) as fast or faster than the current standard methods used by patients and doctors to detect such infections.
NCT05450523
According to the requirements of the "Technical Guidelines for Clinical Trials of In Vitro Diagnostic Reagents", the first registered product (hereinafter referred to as the assessment reagent) - Neutrophil Gelatinase-Associated Lipocalin (NGAL) Rapid Test (Colloidal Gold) was tested in clinical institutions. ) for clinical validation trials. Prove that the clinical performance of the assessment reagent meets the requirements of the intended use.
NCT03685747
Vancomycin is the most commonly used empiric treatment for infectious peritonitis in patients on peritoneal dialysis. Current dosing and monitoring for safety and efficacy is empiric, especially for those on rapid-cycling modalities. The goal of this study is to understand the pharmacokinetics of vancomycin in patients on rapid-cycling peritoneal dialysis modalities in order to derive an optimal dosing regimen.
NCT03675854
Background According to the International Society for Peritoneal Dialysis (ISPD) recommendations, "low-risk" peritoneal dialysis (PD)- related peritonitis caused by coagulase-negative staphylococcal species, Streptococcal species, or negative bacterial culture should receive antibiotics for 2 weeks. However, relapsing, recurrent, or repeated episodes are common. Objectives To compare the incidence of relapsing, recurrent, and repeat peritonitis with a 3-week course, as compared to the conventional 2-week course, antibiotic for PD-related peritonitis. Hypothesis Treatment of low-risk PD-related peritonitis for 3 weeks reduces the incidence of relapsing, recurrent, and repeat peritonitis. Design and subjects Randomized control trial of 310 episodes of "low-risk" PD-related peritonitis. Study instruments and interventions Patients will be randomized to receive treatment of the effective antibiotic according to the ISPD recommendations for 2 weeks (Conventional Group) or 3 weeks (Extended Group). All patients will be followed for 6 months after completion of treatment. Main outcome measures Complete cure of the peritonitis episode, defined as survival for 6 months without relapsing, recurrent, or repeat peritonitis episodes. Data analysis Data will be analyzed by both intention-to-treat and per protocol approach. The incidences of complete cure, relapsing, recurrent, and repeated peritonitis episodes will be compared. Expected results Based on our pilot study, we expect to find a significantly lower rate of relapsing, recurrent, and repeated peritonitis episodes in the Extended Group. By proving that "low-risk" peritonitis episodes require 3-week course of antibiotic therapy, our result will change the current recommendation and make treatment for 3 weeks course the standard of care.