The Role and Mechanism of O-GlcNAc Glycosylation Modified HAS2 in the Hyaluronic Acid Synthesis in ARDS

Hyaluronic Acid Clinical Trial

Official title:

The Role and Mechanism of O-GlcNAc Glycosylation Modified HAS2 in the Hyaluronic Acid Synthesis in ARDS

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05055557
• Other study ID #: ZDHMWHA
• Status: Not yet recruiting
• Start date: October 1, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: September 2021
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 30, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyaluronic Acid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day fatality Rate	28-day mortality (patients will be followed for 28 days)	28 days after enrollment
Primary	90-day fatality rate	90-day mortality (patients will be followed for 90 days)	90 days after enrollment
Primary	ICU hospital stay	Length of ICU stay	through study completion, an average of 4 week
Primary	ICU fatality rate	The ratio of the total number of deaths from all causes of the enrolled patients during ICU hospitalization.	through study completion, an average of 4 week
Primary	Wearing time from mechanical ventilation	successful weaning defined as the absence of the requirement for ventilatory support, without reintubation	through study completion,an average of 4 week
Primary	Peripheral blood HMW-HA and LMW-HA levels	ELISA method to separate and detect HMW-HA and LMW-HA levels(Units of Measure unit nM/ml)	0, 1, 3, 7 days after enrollment
Primary	HAS2 protein content in peripheral blood	ELISA method detects HAS2 protein in peripheral blood	0, 1, 3, 7 days after enrollment
Secondary	ENOS, ET-1, vWF levels in peripheral blood	ELISA method to detect eNOS, ET-1, vWF in peripheral blood to evaluate endothelial cell damage(Measure unit ng/ml)	0, 1, 3, 7 days after enrollment
Secondary	Levels of bound mucinoglycans-1, nitric oxide, and acetylheparin sulfate in peripheral blood	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)	0, 1, 3, 7 days after enrollment
Secondary	In peripheral blood, IL-1a, IL-6, neutrophils, lymphocytes, descending Procalcin, C-reactive protein value	The ELISA method detects IL-1a 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)	0, 1, 3, 7 days after enrollment