Tokyo, Aug. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058809) titled 'Assessment of the Invasiveness of Dialysis Therapy Using Estimated Continuous Cardiac Output Monitoring' on Aug. 15.

Study Type: Observational

Primary Sponsor: Institute - CHUBU UNIVERSITY

Condition: Condition - Chronic Kidney Disease(CKD),maintenance dialysis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Dialysis therapy, while essential for managing end-stage renal disease (ESRD) in patients with chronic kidney disease (CKD), can be physiologically invasive due to the rapid changes it induces in the internal environment over a short period of time. One of the common complications during dialysis is intradialytic hypotension (IDH). Sudden drops in blood pressure during dialysis have been associated with poor clinical outcomes. Therefore, there is a growing demand for monitoring devices capable of early detection of blood pressure drops and prompt notification to medical personnel. In this study, we aim to collect and analyze various hemodynamic parameters in dialysis patients using dialysis session data and non-invasive estimated continuous cardiac output (esCCO). Through this analysis, we seek to evaluate the circulatory changes caused by dialysis therapy from a multidimensional perspective and better understand its physiological impact. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - As this study is exploratory in nature, we set the target sample size at 100 patients (or 100 dialysis sessions) based on the number that could be feasibly recruited during the study period. In routine dialysis treatment, the proportion of patients who experience adverse events, such as sudden drops in blood pressure or vomiting, is expected to be only a few percent, assuming that dialysis is performed safely. However, this study requires collecting data from patients who experience or are suspected to experience deterioration during dialysis. Analyzing such data is crucial for exploring ways to prevent adverse events and ensure safer dialysis treatment. Additionally, due to the lack of prior research using esCCO data from patients who have undergone dialysis without complications, accumulating such data during treatment is of significant value. Considering the need for statistical analysis of various parameters, we determined that a sample size of 100 patients (or 100 dialysis sessions) is appropriate. Key exclusion criteria - Exclusion Criteria: 1) Patients with supraventricular arrhythmias, such as atrial fibrillation, atrial flutter, or sinus arrhythmia, that were present prior to the initiation of dialysis. 2) Patients with frequent premature contractions, such as bigeminy or trigeminy. 3) Patients with implanted pacemakers. 4) Patients who may become agitated due to sensor attachment could potentially compromise the safety of dialysis treatment. 5) Patients whose consent cannot be clearly confirmed. Target Size - 100

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 04 Month 17 Day Date of IRB - 2025 Year 04 Month 17 Day Anticipated trial start date - 2025 Year 06 Month 01 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065572

Disclaimer: Curated by HT Syndication.