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

NCT05055557 | Unknown DMC

• 1 other identifier: ZDHMWHA
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Keywords

Acute respiratory distress syndrome; Pulmonary microvascular endothelial barrier;; Hyaluronic acid; Hyaluronic acid synthase 2

Outcome Measures

Primary Outcomes (7)

• 28-day fatality Rate

  28-day mortality (patients will be followed for 28 days)

  28 days after enrollment

• 90-day fatality rate

  90-day mortality (patients will be followed for 90 days)

  90 days after enrollment

• ICU hospital stay

  Length of ICU stay

  through study completion, an average of 4 week

• 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

• 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

• 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

• HAS2 protein content in peripheral blood

  ELISA method detects HAS2 protein in peripheral blood

  0, 1, 3, 7 days after enrollment

Secondary Outcomes (3)

• ENOS, ET-1, vWF levels in peripheral blood

  0, 1, 3, 7 days after enrollment

• Levels of bound mucinoglycans-1, nitric oxide, and acetylheparin sulfate in peripheral blood

  0, 1, 3, 7 days after enrollment

• In peripheral blood, IL-1α, IL-6, neutrophils, lymphocytes, descending Procalcin, C-reactive protein value

  0, 1, 3, 7 days after enrollment

Study Arms (3)

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

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.

healthy adult group

Healthy adults, voluntarily join the study.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).
• Diagnosis of ARDS less than 72 hours.

You may not qualify if:

• All patients who meet any of the following criteria will be excluded at enrollment and randomization.
• Severe chronic respiratory diseases requiring long-term home oxygen therapy or noninvasive MV.
• Undrained pneumothorax or subcutaneous emphysema.
• Severe neuromuscular disease.
• 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) .
• Contraindications to hypercapnia, such as intracranial hypertension or acute coronary syndrome.
• Severe other organs dysfunction with a low expected survival (7 days) or palliative care.
• Solid organ or hematologic tumors with the expected survival time less than 30 days.
• Participating in other clinical trials within 30 days.
• Pregnancy.
• Refusal to sign the informed consent.

Sponsors & Collaborators

• Southeast University, China: lead

Biospecimen

Retention: SAMPLES WITH DNA

whole blood samples

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 12, 2021
• First Posted: September 24, 2021
• Study Start: October 1, 2021
• Primary Completion: July 31, 2022
• Study Completion: September 30, 2022
• Last Updated: September 24, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share