Hyaluronic AcidNCT05055557
The Role and Mechanism of O-GlcNAc Glycosylation Modified HAS2 in the Hyaluronic Acid Synthesis in ARDS
An observational study of Hyaluronic Acid, run by Southeast University, China.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyaluronic Acid
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2021to 30 Sep 2022
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
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
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day fatality Rate
28-day mortality (patients will be followed for 28 days)
Measured: 28 days after enrollment
90-day fatality rate
90-day mortality (patients will be followed for 90 days)
Measured: 90 days after enrollment
ICU hospital stay
Length of ICU stay
Measured: 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.
Measured: 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
Measured: 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）
Measured: 0, 1, 3, 7 days after enrollment
HAS2 protein content in peripheral blood
ELISA method detects HAS2 protein in peripheral blood
Measured: 0, 1, 3, 7 days after enrollment
Secondary outcomes (3)
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）
Measured: 0, 1, 3, 7 days after enrollment
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）
Measured: 0, 1, 3, 7 days after enrollment
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）
Measured: 0, 1, 3, 7 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start1 Oct 2021 (estimated)
- Primary completion31 Jul 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyaluronic AcidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055557
- Sponsor's protocol ID
- ZDHMWHA
- Status last verified
- Sep 2021
- First submitted
- 12 Sep 2021
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role and Mechanism of O-GlcNAc Glycosylation Modified HAS2 in the Hyaluronic Acid Synthesis in ARDS
- ClinicalTrials.gov ID
- NCT05055557
- Acronym / sponsor ID
- ZDHMWHA
- Conditions
- Hyaluronic Acid
- Keywords
- Acute respiratory distress syndrome, Pulmonary microvascular endothelial barrier;, Hyaluronic acid, Hyaluronic acid synthase 2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 24 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (11 listed)
- 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) .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
28-day fatality Rate
Time frame: 28 days after enrollment
28-day mortality (patients will be followed for 28 days)
90-day fatality rate
Time frame: 90 days after enrollment
90-day mortality (patients will be followed for 90 days)
ICU hospital stay
Time frame: through study completion, an average of 4 week
Length of ICU stay
ICU fatality rate
Time frame: through study completion, an average of 4 week
The ratio of the total number of deaths from all causes of the enrolled patients during ICU hospitalization.
Wearing time from mechanical ventilation
Time frame: through study completion，an average of 4 week
successful weaning defined as the absence of the requirement for ventilatory support, without reintubation
Peripheral blood HMW-HA and LMW-HA levels
Time frame: 0, 1, 3, 7 days after enrollment
ELISA method to separate and detect HMW-HA and LMW-HA levels（Units of Measure unit nM/ml）
HAS2 protein content in peripheral blood
Time frame: 0, 1, 3, 7 days after enrollment
ELISA method detects HAS2 protein in peripheral blood
3 secondary outcomes
ENOS, ET-1, vWF levels in peripheral blood
Time frame: 0, 1, 3, 7 days after enrollment
Levels of bound mucinoglycans-1, nitric oxide, and acetylheparin sulfate in peripheral blood
Time frame: 0, 1, 3, 7 days after enrollment
In peripheral blood, IL-1α, IL-6, neutrophils, lymphocytes, descending Procalcin, C-reactive protein value
Time frame: 0, 1, 3, 7 days after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyaluronic Acid, run by Southeast University, China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day fatality Rate (time frame: 28 days after enrollment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2021.