跳至主要内容
临床试验/CTRI/2025/08/092724
CTRI/2025/08/092724尚未招募不适用

Role of Speckle tracking echocardiography in patients with sepsis and septic shock: A case control study

ESIC Medical College and Hospital, Faridabad1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年8月19日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
1.To measure the LV global longitudinal strain (GLS) and RV strain using 2D speckle-tracking echocardiography and classify the degree of myocardial impairment in both sepsis and septic shock patients.

研究概览

简要总结

All patients admitted to the Intensive Care Unit in the Department of Critical Care Medicine at ESIC Medical College Faridabad will be screened for sepsis in accordance with the Sepsis 3 definition. Screening will occur either at the time of admission or within twenty four hours prior to ICU admission to determine eligibility for the study.

The patients will be retrospectively divided into two groups. The study group will consist of patients diagnosed with septic shock. The control group will include patients with sepsis who did not develop septic shock. Both groups will be matched for age and sex in order to minimize bias and allow accurate comparisons.

Each enrolled patient will undergo a detailed clinical history and physical examination. Baseline clinical data will be recorded, including age, gender, presence of comorbidities, hemodynamic parameters, vasopressor requirements, and severity scores such as the Sequential Organ Failure Assessment score and the Acute Physiology and Chronic Health Evaluation II score. These parameters will be documented on the day of ICU admission.

The probable source of infection will be determined using appropriate culture techniques including analysis of sputum, blood, urine, cerebrospinal fluid, and serous body fluids. All patients will undergo both routine laboratory investigations and specific tests as clinically indicated.

Echocardiographic assessments will be conducted at defined time points. In the study group of patients with septic shock, the first transthoracic echocardiography will be performed within twenty four hours of ICU admission. A second echocardiogram will be conducted seventy two hours after the first, and a third examination will be carried out at the time of clinical recovery, which is defined as the point when all vasopressors and inotropic support have been discontinued.

In the control group of patients with sepsis but without shock, the first transthoracic echocardiography will also be performed within twenty four hours of diagnosis. The second echocardiography will be done seventy two hours later, and the third will be carried out either on the seventh day or at the time of antibiotic deescalation, whichever occurs later.

All echocardiographic examinations will be performed by a single trained and certified cardiologist with expertise in echocardiography. The procedure will be done with the patient in the supine or left lateral position using a three point five megahertz ultrasound transducer. All image data will be recorded and stored in digital cine loop format for further analysis.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Newly diagnosed cases of sepsis and septic shock as per sepsis 3 definition 2.Age 18-60 years.

排除标准

  • 1.Use of inotropes and vasopressors 24hrs prior to ICU admission 2.Insufficient echocardiographic image quality 3.Patient or relatives declining participation 4.Prescence of acute myocardial infarction, myocarditis and cardiac arrythmia 5.Post -cardiopulmonary resuscitation 6.Previous history of congenital heart disease, valvular heart disease, cardiomyopathy, and chronic heart failure.

结局指标

主要结局

1.To measure the LV global longitudinal strain (GLS) and RV strain using 2D speckle-tracking echocardiography and classify the degree of myocardial impairment in both sepsis and septic shock patients.

时间窗: Within 24 hours , at 72 hours and at 7 days or at recovery

2.To assess left ventricular (LV) and right ventricular (RV) function in patients with sepsis and septic shock using conventional echocardiographic parameters within 24 hours of ICU admission and at the time of recovery.

时间窗: Within 24 hours , at 72 hours and at 7 days or at recovery

次要结局

  • To evaluate the reversibility of cardiac dysfunction in septic shock patients by performing a follow-up echocardiography at recovery (defined as discontinuation of inotropes or vasopressors).(Within 24 hours , at 72 hours and at 7 days or at recovery)

研究者

发起方
ESIC Medical College and Hospital, Faridabad
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Mohit

ESIC Medical College and Hospital, Faridabad

研究点 (1)

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