The Role and Mechanism of O-GlcNAc Glycosylation Modified HAS2 in the Hyaluronic Acid Synthesis in ARDS
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 主要终点
- ICU hospital stay
研究概览
简要总结
Maintaining the normal function of the pulmonary microvascular barrier is critical for ARDS treatment. To assess the relationship between the HAS2 protein level, HA content and the clinical prognosis of ARDS in patients with ARDS. Compare the HAS2 protein levels, HMW-HA and LMW-HA levels, endothelial injury indicators, and lungs in the blood of severe and non-ARDS severe patients and healthy adults admitted to the ICU. The correlation between permeability, disease severity and prognosis to explore the predictability of HAS2-HA on the clinical outcome of ARDS.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1.85 years≥Age≥18 years. 2.Moderate-to-severe ARDS, defined by the ARDS Definition Task Force in the Berlin definition (partial pressure of arterial oxygen [PaO2]:FiO2 ratio ≤200 mmHg with a PEEP ≥5 cmH2O).
- •3.Diagnosis of ARDS less than 72 hours.
排除标准
- •All patients who meet any of the following criteria will be excluded at enrollment and randomization.
- •Severe chronic respiratory diseases requiring long-term home oxygen therapy or noninvasive MV.
- •Undrained pneumothorax or subcutaneous emphysema.
- •Severe neuromuscular disease.
- •Hemodynamic instability (>30% increase in vasopressors within 6 hours or norepinephrine >0.5 ug/kg/min) (Am J Respir Crit Care Med. 2020; 201(2):178-187) .
- •Contraindications to hypercapnia, such as intracranial hypertension or acute coronary syndrome.
- •Severe other organs dysfunction with a low expected survival (7 days) or palliative care.
- •Solid organ or hematologic tumors with the expected survival time less than 30 days.
- •Participating in other clinical trials within 30 days.
- •Refusal to sign the informed consent.
结局指标
主要结局
ICU hospital stay
时间窗: through study completion, an average of 4 week
Length of ICU stay
Wearing time from mechanical ventilation
时间窗: through study completion，an average of 4 week
successful weaning defined as the absence of the requirement for ventilatory support, without reintubation
HAS2 protein content in peripheral blood
时间窗: 0, 1, 3, 7 days after enrollment
ELISA method detects HAS2 protein in peripheral blood
28-day fatality Rate
时间窗: 28 days after enrollment
28-day mortality (patients will be followed for 28 days)
90-day fatality rate
时间窗: 90 days after enrollment
90-day mortality (patients will be followed for 90 days)
ICU fatality rate
时间窗: through study completion, an average of 4 week
The ratio of the total number of deaths from all causes of the enrolled patients during ICU hospitalization.
Peripheral blood HMW-HA and LMW-HA levels
时间窗: 0, 1, 3, 7 days after enrollment
ELISA method to separate and detect HMW-HA and LMW-HA levels（Units of Measure unit nM/ml）
次要结局
- Levels of bound mucinoglycans-1, nitric oxide, and acetylheparin sulfate in peripheral blood(0, 1, 3, 7 days after enrollment)
- ENOS, ET-1, vWF levels in peripheral blood(0, 1, 3, 7 days after enrollment)
- In peripheral blood, IL-1α, IL-6, neutrophils, lymphocytes, descending Procalcin, C-reactive protein value(0, 1, 3, 7 days after enrollment)
研究者
Ling Liu
professor
Southeast University, China