Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062873) titled 'A Study to Improve Cardiogenic Shock Treatment and Transfer to Specialized Hospitals in Japan' on Oct. 1.

Study Type: Observational

Primary Sponsor: Institute - Kumamoto University

Condition: Condition - Cardiogenic shock Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - With an aging patient population, an increasing burden of comorbidities, greater disease severity, and expanding therapeutic options, cardiovascular critical care has become increasingly specialized. Nevertheless, the prognosis of cardiogenic shock remains poor worldwide, with studies from Japan reporting a 30-day mortality rate exceeding 30%. In recent years, regionalization of care through a Hub-and-Spoke model has been proposed as a potential strategy to address shortages of specialized physicians and optimize the delivery of care for critically ill patients. However, no studies have evaluated the effectiveness of such a model in Japan. Therefore, establishing evidence for cardiovascular critical care at the regional healthcare-system level, rather than solely at the individual patient level, is an urgent priority in Japan. The aim of this study is to (1) evaluate the effectiveness of regionalizing care for critically ill patients through a Hub-and-Spoke model and (2) generate evidence to improve the management and outcomes of patients with cardiogenic shock. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - The study will include patients aged 18 years or greater with cardiogenic shock or severe heart failure who are admitted to an intensive care unit (ICU), cardiac care unit (CCU), or high care unit (HCU) at a participating institution. Cardiogenic shock will be defined as systolic blood pressure less than 90 mmHg accompanied by evidence of tissue hypoperfusion, including at least one of the following: cold extremities, oliguria, or a serum lactate level 2 mmol/L or higher. Severe heart failure will be defined as heart failure with low cardiac output and/or organ congestion requiring inotropic therapy or mechanical circulatory support. Key exclusion criteria - Patients aged 18-years or less Target Size - 600

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 12 Day Date of IRB - 2016 Year 06 Month 12 Day Anticipated trial start date - 2026 Year 10 Month 01 Day Last follow-up date - 2030 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071978

Disclaimer: Curated by HT Syndication.