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Clinical Study of Dipyridamole Tablets in the Treatment of Acute Respiratory Distress Syndrome

Clinical Study of Dipyridamole Tablets in the Treatment of Acute Respiratory Distress Syndrome

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078059
Enrollment
Unknown
Registered
2023-11-28
Start date
2023-12-01
Completion date
Unknown
Last updated
2023-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome

Interventions

Experimental group:Standard treatment combined with Dipyridamole tablets
Control group:Standard treatment
Healthy cases:NA

Sponsors

the First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Healthy volunteers: ? Healthy volunteers, regardless of gender, ? Age = 18 years old and voluntarily sign a written informed consent form, ? Healthy volunteers have a thorough understanding of the experimental content, process, benefits, and potential adverse reactions, voluntarily participate and can complete this study in accordance with the experimental protocol requirements. ARDS patients: ? Age = 18 years old and voluntarily agreed or authorized legal representative to sign a written informed consent form, ? Compliant with the ARDS diagnostic criteria [2012 Berlin ARDS diagnostic criteria]: 1. Identify the cause of acute or progressive dyspnea that occurs within one week. 2. Chest X-ray plain film/chest CT shows bilateral lung infiltration shadows, which cannot be fully explained by pleural effusion, lobar/whole lung atelectasis, and nodular shadows. 3. Respiratory failure cannot be fully explained by heart failure and fluid overload. If there are no risk factors in clinical practice, objective examinations (such as echocardiography) are needed to evaluate cardiogenic pulmonary edema. 4. Hypoxemia is diagnosed with ARDS based on PaO2/FiO2 and classified into mild, moderate, and severe levels according to severity. It should be noted that the monitoring of PaO2 in the oxygenation index mentioned above is measured under the condition of mechanical ventilation parameters PEEP/CPAP not less than 5cmH2O; When the altitude of the location exceeds 1000m, PaO2/FiO2 needs to be corrected, and the corrected PaO2/FiO2=(PaO2/FiO2) x (atmospheric pressure value of the location/760). Or [New Global Definition of ARDS]: 1. Patients with HFNO (nasal high flow) treatment = 30L/min can be included, 2. Pulse oximeter measurement of blood oxygen saturation can replace arterial blood gas diagnosis for ARDS, 3. Patients in resource-limited environments will no longer be excluded from the definition of ARDS and can be included in epidemiological and clinical studies, including clinical trials, When chest X-ray and/or CT are not easily obtainable, ultrasound can be used for imaging, provided that the operator is well-trained. ? During the treatment period, there is a traceable medical history record and the medical record is complete.

Exclusion criteria

Exclusion criteria: ? Disagree with the participants; ? Age = 18 years old; ? Pregnancy or lactation status; ? Diagnosis ARDS>48 hours; ? Expected survival<24 hours; ? Unstable vital signs; ? Allergic history of dipyridamole; ? Hemorrhagic diseases; ? Low blood pressure status Simultaneously undergoing dual antithrombotic therapy; Participants in other clinical trials within the past three months; Researchers believe that it is not suitable to participate in clinical trials or cannot complete this study due to other reasons.

Design outcomes

Primary

MeasureTime frame
All-cause mortality rate;

Secondary

MeasureTime frame
SOFA score;Ventilator-free days;Change in lung injury score from baseline;Improvement in chest CT;Oxygenation index;Hospital mortality rate;

Countries

China

Contacts

Public ContactFan Xiaoyun

the First Affiliated Hospital of Anhui Medical University

1395698852@126.com+86 139 5698 8552

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026