Clinical Trial: Evaluation of Agreement Between Shunt and Non-shunt Limb SpO2 Measurements During Hemodialysis (Japan)

Tokyo, Oct. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059287) titled 'Evaluation of Agreement Between Shunt and Non-shunt Limb SpO2 Measurements During Hemodialysis' on Oct. 4.

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 - During hemodialysis, both SpO2 and non-invasive blood pressure (NIBP) are measured on the non-shunt limb. However, during NIBP measurement, the SpO2 signal diminishes or is interrupted, compromising the reliability and continuity of SpO2 monitoring. Decreased SpO2 during hemodialysis can serve as an important early indicator suggesting hypotension, dehydration, or cardiovascular events associated with reduced circulating blood volume due to fluid removal, rapid changes in electrolyte and osmolarity, or the influence of dialysate temperature. However, the reduction or interruption of the SpO2 signal can delay the detection of such pathological changes, potentially increasing the risk of delayed intervention and worsening outcomes. Therefore, this study aims to evaluate the consistency of SpO2 measurements between the shunt limb and the non-shunt limb to verify the feasibility of using the shunt limb as an alternative site for SpO2 monitoring during hemodialysis. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Chronic kidney disease patients receiving maintenance hemodialysis at the trial site Key exclusion criteria - 1)Patients suspected of having peripheral ischemia 2)Patients for whom obtaining consent for the study is difficult Target Size - 40

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2021 Year 02 Month 26 Day Date of IRB - 2021 Year 02 Month 26 Day Anticipated trial start date - 2021 Year 04 Month 01 Day Last follow-up date - 2026 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067808

Disclaimer: Curated by HT Syndication.