跳至主要内容
临床试验/NCT05161104
NCT05161104Enrolling By Invitation不适用

A Multicenter Cross-sectional Study of Cardiac Ultrasound Phenotypes in Patients With Sepsis

Fujian Provincial Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年11月23日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
200
试验地点
1
主要终点
28-day mortality

研究概览

简要总结

The heart, one of the most important organs for oxygen supply and consumption, is frequently involved in sepsis, i.e. septic cardiomyopathy, also known as septic myocardial suppression. The occurrence of septic myocardial suppression increases mortality in septic patients. Recent studies have found that left ventricular hyperdynamic state (EF > 70%) is associated with intra-ICU mortality in septic patients, possibly because it reflects unresolved vascular paralysis from sepsis . For septic myocardial suppression, there is still a lack of uniform criteria for diagnosis, but it is well established that the cardiac ultrasound phenotype of septic myocardial suppression can be left ventricular systolic insufficiency (LVSD), left ventricular diastolic insufficiency (LVDD), right ventricular insufficiency (RVD), diffuse ventricular insufficiency, and mixed ventricular insufficiency. According to incomplete statistics, the prevalence of LVSD ranges from 12 to 60%, the prevalence of LVDD is higher, 20% to 79%, and the prevalence of RVD varies from 30% to 55%. However, based on the current understanding of septic myocardial suppression, the relationship between each staging and its prognosis is unclear, and echocardiography can rapidly identify septic myocardial suppression and guide the classification of septic myocardial suppression to further optimize the diagnosis and treatment process of sepsis, especially to avoid over-resuscitation during fluid resuscitation and perform reverse resuscitation in a timely manner to improve patient prognosis and reduce hospitalization time. The aim of this study is to classify and evaluate the prognosis of patients with different septic cardiac ultrasound phenotypes in multiple centers across China by measuring the right and left heart systolic and diastolic indices by echocardiography, recording the baseline conditions and clinical indices of patients, and combining them with the prognosis.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

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 with sepsis or septic shock who conform to Sepsis 3.0 diagnostic criteria

排除标准

  • Patients with preexisting chronic heart disease such as cardiomyopathy, chronic pulmonary heart disease, severe cardiac valve disease, coronary heart disease, congenital heart disease, pericardial disease, etc. and with cardiac function ≥ grade III (NYHA classification) prior to sepsis.
  • End-stage malignancies.
  • Severe trauma.
  • Patients for whom transthoracic echocardiography data are not available.

结局指标

主要结局

28-day mortality

时间窗: From patient admission to day 28

Number of patient deaths within 28 days divided by the total number

in-hospital mortality

时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

Number of patient deaths divided by the total number

次要结局

  • number of days of mechanical ventilation(Days the patient was mechanically ventilated until the cessation of mechanical ventilation,an average of 1 week)
  • length of stay in the ICU(days from patient transfer to ICU to transfer out,an average of 1 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiuling Shang

Clinical Professor

Fujian Provincial Hospital

研究点 (1)

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