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

S

Southeast University, China

Status

Unknown

Conditions

Hyaluronic Acid

Study type

Observational

Funder types

Other

Identifiers

NCT05055557
ZDHMWHA

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

60 participants in 3 patient groups

ARDS group
Description:
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
Critically ill patients without ARDS group
Description:
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.
healthy adult group
Description:
Healthy adults, voluntarily join the study.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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