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Status unknownNCT05055557Updated Sep 24, 2021

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

An observational study in Hyaluronic Acid, sponsored by Southeast University, China. Status unknown. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-24.

Sponsored by Southeast University, China · Observational

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hyaluronic Acid

Keywords

  • Acute respiratory distress syndrome
  • Pulmonary microvascular endothelial barrier;
  • Hyaluronic acid
  • Hyaluronic acid synthase 2
03

In context

Lead sponsor

Southeast University, China is the lead sponsor of 164 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Target follow-up
3 Months
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 28-day fatality Rate

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

    Time frame: 28 days after enrollment

  2. 90-day fatality rate

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

    Time frame: 90 days after enrollment

  3. ICU hospital stay

    Length of ICU stay

    Time frame: through study completion, an average of 4 week

  4. ICU fatality rate

    The ratio of the total number of deaths from all causes of the enrolled patients during ICU hospitalization.

    Time frame: through study completion, an average of 4 week

  5. Wearing time from mechanical ventilation

    successful weaning defined as the absence of the requirement for ventilatory support, without reintubation

    Time frame: through study completion,an average of 4 week

  6. 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)

    Time frame: 0, 1, 3, 7 days after enrollment

  7. HAS2 protein content in peripheral blood

    ELISA method detects HAS2 protein in peripheral blood

    Time frame: 0, 1, 3, 7 days after enrollment

Secondary outcomes

  1. 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)

    Time frame: 0, 1, 3, 7 days after enrollment

  2. 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)

    Time frame: 0, 1, 3, 7 days after enrollment

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

    The ELISA method detects IL-1α 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)

    Time frame: 0, 1, 3, 7 days after enrollment

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05055557
Lead sponsor
Southeast University, China
Responsible party
Ling Liu (professor, Southeast University, China) — Principal investigator
First posted
Sep 24, 2021
Start date
Oct 1, 2021 (estimated)
Primary completion
Jul 31, 2022 (estimated)
Completion
Sep 30, 2022 (estimated)
Last update
Sep 24, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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