Hyaluronic Acid
Conditions
Keywords
Acute respiratory distress syndrome, Pulmonary microvascular endothelial barrier;, Hyaluronic acid, Hyaluronic acid synthase 2
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.
Interventions
None listed
Sponsors
Southeast University, China
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Exclusion criteria
All patients who meet any of the following criteria will be excluded at enrollment and randomization. 1. Severe chronic respiratory diseases requiring long-term home oxygen therapy or noninvasive MV. 2. Undrained pneumothorax or subcutaneous emphysema. 3. Severe neuromuscular disease. 4. 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) . 5. Contraindications to hypercapnia, such as intracranial hypertension or acute coronary syndrome. 6. Severe other organs dysfunction with a low expected survival (7 days) or palliative care. 7. Solid organ or hematologic tumors with the expected survival time less than 30 days. 8. Participating in other clinical trials within 30 days. 9. Pregnancy. 10. Refusal to sign the informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HAS2 protein content in peripheral blood | 0, 1, 3, 7 days after enrollment | ELISA method detects HAS2 protein in peripheral blood |
| 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. |
| 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 |
| 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） |
| 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 hospital stay | through study completion, an average of 4 week | Length of ICU stay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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） |
| 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） |
| 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） |
Outcome results
None listed