Clinical Trial: A Randomized Controlled Trial to Evaluate the Efficacy of Frequent Peritoneal Dialysis for Peritoneal Dialysis-Associated Peritonitis (Japan)

Tokyo, July 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062152) titled 'A Randomized Controlled Trial to Evaluate the Efficacy of Frequent Peritoneal Dialysis for Peritoneal Dialysis-Associated Peritonitis' on July 23.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - The Jikei University

Condition: Condition - Peritoneal Dialysis-Related Peritonitis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This randomized controlled trial aims to determine the efficacy of a procedure (intervention) involving frequent dialysis using an approved peritoneal dialysis solution in patients with peritoneal dialysis-associated peritonitis (PD-associated peritonitis). This study is not intended to evaluate the pharmacological effects or off-label uses of a specific dialysis solution, but rather to verify the superiority of frequent dialysis as a therapeutic procedure. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - control Interventions/Control_2 - frequent peritoneal dialysis

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - 1)Patients who meet the diagnostic criteria for PD-associated peritonitis must: They must meet at least two of the following criteria: - Clinical symptoms suggestive of peritonitis, such as abdominal pain or cloudy dialysate. - White blood cell count in the dialysate of 100/microL or higher (with a neutrophil percentage of 50% or higher). - Positive Gram stain or culture of the effusion. 2) Age: Patients must be aged 18 years or over at the time informed consent is obtained. 3) Participating institutions: Patients undergoing peritoneal dialysis at one of the four Jikei University hospitals. 4) Informed consent: Patients who have provided written consent to participate in this study. Key exclusion criteria - 1) Severe systemic condition: Patients for whom urgent systemic management or surgical intervention is a higher priority than frequent dialysis procedures, such as those with septic shock or impaired consciousness. 2) Fungal or tuberculous peritonitis: Patients in whom infection by a specific pathogen that is difficult to treat with standard frequent dialysis procedures or antibiotic therapy is strongly suspected. 3) Physical damage to the catheter itself: Patients for whom fluid exchange is difficult and frequent dialysis procedures cannot be performed. 4) Recent participation history: Patients who participated in this study within the past 30 days and have experienced a relapse of peritonitis, as this is considered a continuation of the same episode. 5) Other: Patients deemed unsuitable for participation in this study by the principal investigator or a co-investigator. Target Size - 40

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 06 Month 29 Day Date of IRB - 2026 Year 06 Month 10 Day Anticipated trial start date - 2026 Year 07 Month 23 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071041

Disclaimer: Curated by HT Syndication.