Clinical trial NCT05055557: The Role and Mechanism of O-GlcNAc Glycosylation Modified HAS2 in the Hyaluronic Acid Synthesis in ARDS
Official title: The Role and Mechanism of O-GlcNAc Glycosylation Modified HAS2 in the Hyaluronic Acid Synthesis in ARDS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hyaluronic Acid
Keywords: Acute respiratory distress syndrome
Pulmonary microvascular endothelial barrier;
Hyaluronic acid
Hyaluronic acid synthase 2
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2021-09-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 28-day fatality Rate
timeFrame: 28 days after enrollment
measure: 90-day fatality rate
timeFrame: 90 days after enrollment
measure: ICU hospital stay
timeFrame: through study completion, an average of 4 week
measure: ICU fatality rate
timeFrame: through study completion, an average of 4 week
measure: Wearing time from mechanical ventilation
timeFrame: through study completion，an average of 4 week
measure: Peripheral blood HMW-HA and LMW-HA levels
timeFrame: 0, 1, 3, 7 days after enrollment
measure: HAS2 protein content in peripheral blood
timeFrame: 0, 1, 3, 7 days after enrollment
Secondary outcomes:
measure: ENOS, ET-1, vWF levels in peripheral blood
timeFrame: 0, 1, 3, 7 days after enrollment
measure: Levels of bound mucinoglycans-1, nitric oxide, and acetylheparin sulfate in peripheral blood
timeFrame: 0, 1, 3, 7 days after enrollment
measure: In peripheral blood, IL-1α, IL-6, neutrophils, lymphocytes, descending Procalcin, C-reactive protein value
timeFrame: 0, 1, 3, 7 days after enrollment
Other outcomes:
Locations:
Study officials:
References: