The Role and Mechanism of O-GlcNAc Glycosylation Modified HAS2 in the Hyaluronic Acid Synthesis in ARDS
- Conditions
- Hyaluronic Acid
- Registration Number
- NCT05055557
- Lead Sponsor
- Southeast University, China
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
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.
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.
- Pregnancy.
- Refusal to sign the informed consent.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ICU hospital stay through study completion, an average of 4 week Length of ICU stay
Wearing time from mechanical ventilation 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 0, 1, 3, 7 days after enrollment ELISA method detects HAS2 protein in peripheral blood
28-day fatality Rate 28 days after enrollment 28-day mortality (patients will be followed for 28 days)
90-day fatality rate 90 days after enrollment 90-day mortality (patients will be followed for 90 days)
ICU fatality rate 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 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）
- Secondary Outcome Measures
Name Time Method Levels of bound mucinoglycans-1, nitric oxide, and acetylheparin sulfate in peripheral blood 0, 1, 3, 7 days after enrollment glycocalyx levels of the endothelium were assessed by measuring the levels of mucin polysaccharide-1, nitric oxide and acetyl heparan sulfate in peripheral blood by ELISA assay（Measure unit ng/ml）
ENOS, ET-1, vWF levels in peripheral blood 0, 1, 3, 7 days after enrollment ELISA method to detect eNOS, ET-1, vWF in peripheral blood to evaluate endothelial cell damage（Measure unit ng/ml）
In peripheral blood, IL-1α, IL-6, neutrophils, lymphocytes, descending Procalcin, C-reactive protein value 0, 1, 3, 7 days after enrollment The ELISA method detects IL-1α and IL-6 in the blood, and records the blood neutrophils, lymphocytes, and vary in procalcin and C-reactive protein to assess the inflammatory response of ARDS(Measure unit pg/ml）