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临床试验/NCT05552521
NCT05552521已完成不适用

Early Diastolic Dysfunction in Patients With Septic Shock and Its Association With the Presence of Cardiomyopathy Genetic Variants

Hospital Garcia de Orta1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Diastolic dysfunction

研究概览

简要总结

Sepsis is a life-threatening infection with increasing incidence, and its spectrum of disease can involve cardiac dysfunction, which further adds to mortality. Although cardiac involvement in sepsis has been classically attributed to systolic dysfunction, diastolic dysfunction is increasingly diagnosed due to new echocardiographic techniques and the conceptual evolution of diastolic dysfunction. Combining systolic and diastolic dysfunction assessment could lead to a better diagnosis of septic cardiac dysfunction. Furthermore, earlier forms of septic cardiac dysfunction could be more promptly recognized by measuring novel and less used parameters of diastolic dysfunction. We hypothesize that left atrium (LA) strain and isovolumetric relaxation time (IVRT) derived intervals could be new and earlier predictors of diastolic dysfunction in septic patients with a potential impact on clinical presentation and prognosis and that rare genetic variation associated with inherited cardiomyopathies could underline the risk and severity of sepsis-related myocardial dysfunction with potential impact on diagnosis and prognosis.

详细描述

Primary outcome:

Presence of diastolic dysfunction at baseline or during evolution in patients presenting with septic shock and its impact on prognosis.

Secondary outcomes:

Development of heart failure symptoms and presence of myocardial dysfunction (either systolic or diastolic) at 30th day, 30-day mortality, mechanical ventilation duration, ICU length of stay, and hospital stay, and need for therapeutic change.

Mid-term prognosis will be assessed at six months follow-up for evaluation of the clinical functional class, LV systolic and diastolic function, and biomarkers.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients admitted in the ICU i. ≥ 18 years old; ii. with septic shock by the sepsis 3.0 criteria (13): Sepsis and (despite adequate volume resuscitation) both of: persistent hypotension requiring vasopressors to maintain MAP greater than or equal to 65 mm Hg, and lactate greater than or equal to 2 mmol/L.

排除标准

  • pregnancy, congenital heart disease, artificial valve prosthesis, severe aortic or mitral pathology, atrial fibrillation, and inadequate image quality.

结局指标

主要结局

Diastolic dysfunction

时间窗: through study completion until 6 months

Left atrium strain in % and IVRTs intervals in msec

Hereditary Cardiomyopathy genetic variants

时间窗: through study completion until 6 months

Search for cardiomyopathies genetic variantes that could explain a myocardial susceptibility to develop injury in septic shock

次要结局

  • Heart failure(through study completion until 6 months)
  • Mortality(through study completion until 6 months)

研究者

发起方
Hospital Garcia de Orta
申办方类型
Other
责任方
Principal Investigator
主要研究者

Filipe André Gonzalez

Senior consultant of Internal Medicine and Intensive Medicine, PhD student

Hospital Garcia de Orta

研究点 (1)

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