Utility of untargeted metabolomics and point of care ultrasound for the prediction of outcomes in ARDS (acute respiratory distress syndrome) patients- A prospective cohort study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Mortality at 28 days from ARDS diagnosis.
研究概览
简要总结
This prospective cohort study aims to evaluate whether certain naturally occurring chemical compounds in the blood (called metabolites) and findings from bedside lung ultrasound can predict outcomes in patients with Acute Respiratory Distress Syndrome (ARDS) who are on mechanical ventilation. The study will analyze the metabolic profiles and biomarker levels of these patients to identify markers that can help forecast disease severity, mortality, and lung mechanics. It will also examine the differences in metabolic patterns between types of ARDS based on inflammation levels and pressure in the lungs. A total of 174 ARDS patients will be included, and for comparison, 50 healthy individuals undergoing routine health check-ups will serve as controls. Blood samples from both groups will be analyzed using gas chromatography mass spectrometry (GCMS) untargeted metabolomics technique. The primary outcome of the study is mortality at 28 days from ARDS diagnosis. Secondary outcomes include the length of ICU stay, and identification of metabolomic signatures associated with higher driving pressure greater than or equal to 16 cm H2O in ARDS patients. The study seeks to identify new biomarkers that can help in early diagnosis and guide treatment decisions in ARDS, especially in resource-limited settings.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •The study will include adult ARDS patients aged 18-80 years of either gender.
- •ARDS should be diagnosed based on the new global definition of ARDS.
排除标准
- •Patients of ARDS on Invasive mechanical ventilation (IMV) greater than 48 hours will be excluded.
- •Patients with lung trauma, chest wall deformities where lung ultrasound may be unreliable will also be excluded.
- •ARDS patients with immunosuppression as defined by a course of corticosteroids lasting more than two weeks at doses exceeding 20 mg of prednisolone per day, will be excluded.
- •Patients with a history of solid organ or bone marrow transplantation, who have been treated with chemotherapy for any type of malignancy, any biological agent, prednisone equivalent of more than 10mg per day and 700 mg cumulative dose, antiproliferative agents and B cell or T cell depletion medications, will be excluded.
- •Also, Pregnant patients with ARDS will be excluded.
结局指标
主要结局
Mortality at 28 days from ARDS diagnosis.
时间窗: 28 days from ARDS diagnosis
次要结局
- Prolonged Length of stay in ICU (greater than 14 days). To identify specific metabolites to reliably predict 28 day mortality in ARDS patients at an early stage of ARDS. Identification of metabolites to predict higher Driving pressure greater than or equal to 16 cm H2O in ARDS patients & also to identify sub phenotype 2 of ARDS.(At Baseline, 2 weeks & 4 weeks.)
研究者
Ms Ashritha A Udupa
Kasturba Medical College, Manipal Academy of Higher Education, Manipal