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

NCT ID: NCT05055557

Last Updated: 2021-09-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2022-09-30

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.

Conditions

Hyaluronic Acid

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ARDS group

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. 4.Just observation

No interventions assigned to this group

Critically ill patients without ARDS group

Unstable vital signs, rapid changes in the condition, unstable function of more than two organ systems (excluding the respiratory system), decline or failure, the development of the disease may endanger the life of the patient.

No interventions assigned to this group

healthy adult group

Healthy adults, voluntarily join the study.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Southeast University, China

OTHER

Sponsor Role: lead

Responsible Party

Ling Liu

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

ZDHMWHA

Identifier Type: -

Identifier Source: org_study_id