跳至主要内容
临床试验/CTRI/2025/01/079664
CTRI/2025/01/079664尚未招募不适用

ARDS henotype and its association with Right ventricle dysfunction trajectory

All India Institute Of Medical Science1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2025年2月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
114
试验地点
1
主要终点
To know the association between ARDS phenotypes (hypo inflammatory vs hyper inflammatory and pulmonary vs extrapulmonary , focal vs diffuse)

研究概览

简要总结

INCLUSION CRITERIA:

1.     Adult patients with ARDS as per Berlin definition10 and expanded definition.11

EXCLUSION CRITERIA

1.     Patients’ refusal

2.     Patient who had cardiac arrest in the recent admission

All patients in ED and ICU who meet the inclusion and exclusion criteria will be screened for enrolment within 24hr of diagnosis of ARDS. 2.5-MHz phased-array probe will be used for echocardiography. There will be no blinding of the clinical status to the investigator at the time of performance of Echocardiography.

The echocardiography will be performed by an experienced investigator who has conducted over 50 point-of-care echocardiograms, and it will be executed by a single observer.

The assessments will take place at the time of the patient’s arrival in the ICU, as well as on Day 1, Day 3, Day 7, and at the time of liberation from the ventilator. The parameters evaluated during the echocardiography will include Left Ventricular End-Diastolic Area (LVEDA), Left Ventricular Ejection Fraction (LVEF), Tricuspid Annular Plane Systolic Excursion (TAPSE), TAPSE/Pulmonary Arterial Systolic Pressure (PASP), TAPSE/Tricuspid Regurgitant Velocity (TRV), Central Venous Pressure (CVP), Inferior Vena Cava (IVC) Diameter, IVC Distensibility, and Pulmonary Artery Acceleration Time.

For each parameter, three measurements will be taken, and the average will be recorded. Additionally, the following ventilator parameters will be noted at the time of echocardiography: compliance, driving pressure, tidal volume, PEEP (Positive End-Expiratory Pressure), and respiratory rate. Basic laboratory parameters, including the P/F ratio (PaO2/FiO2), lactate levels, base excess, C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-18 (IL-18), and the neutrophil-to-lymphocyte ratio (NLR), will also be assessed. Finally, the APACHE (Acute Physiology and Chronic Health Evaluation) and SOFA (Sequential Organ Failure Assessment) scores will be calculated to evaluate the patients’ conditions comprehensively.

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

  • Adult patients with ARDS as per Berlin definition10 and expanded definition.11.

排除标准

  • Patients’ refusal
  • Patient who had cardiac arrest in the recent admission.

结局指标

主要结局

To know the association between ARDS phenotypes (hypo inflammatory vs hyper inflammatory and pulmonary vs extrapulmonary , focal vs diffuse)

时间窗: Day 1,3,7 / Ventilation liberation

pattern of RV dysfunction RV dilatation isolated, RV dilatation with RV-PA uncoupled, RV dilatation with RV function impaired ) with or without shock

时间窗: Day 1,3,7 / Ventilation liberation

次要结局

  • Association between ARDS phenotypes & RV dysfunction trajectory(Association between RV dysfunction pattern & clinical outcome)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Vasundhara Rakhi

ALL INDIA INSTITUTE OF MEDICAL SCIENCE NEW DELHI

研究点 (1)

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