NCT06013319 Effect of Esmolol on Oxygenation Index in Patients With Acute Respiratory Distress Syndrome
| NCT ID | NCT06013319 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Zhiming Jiang |
| Condition | Acute Respiratory Distress Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 178 participants |
| Start Date | 2023-02-20 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 178 participants in total. It began in 2023-02-20 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Acute respiratory distress syndrome (ARDS) is a clinical syndrome caused by intrapulmonary and/or extrapulmonary causes, characterized by intractable hypoxemia. Studies have shown that the sympathetic nervous system is over-activated in patients with acute respiratory distress syndrome. A large retrospective study showed a reduction in mortality in ARDS patients treated with oral β1 blockers before admission, and this beneficial effect of β1 blockers applies to ARDS patients with or without cardiac disease. Esmolol is an ultra-short-acting selective β1 receptor blocker. Previous studies have shown that esmolol can improve oxygenation and reduce the levels of inflammatory cytokines and exudate proteins in bronchoalveolar lavage fluid, thereby alleviating pulmonary injury. According to the literature and our previous clinical observations, we made the following hypothesis: When Estolol is applied to various ARDS patients undergoing mechanical ventilation in ICU, it can control the heart rate by inhibiting β-adrenergic receptor, which can ultimately improve the oxygenation index of patients and shorten the mechanical ventilation time. This project intends to include ARDS patients with optimal hemodynamic treatment for 24 hours, whose heart rate is still ≥95 beats/min after conventional treatment, but ≤120 beats/min. They are randomly divided into control group and Esmolol treatment group to study the effects of esmolol on patients' oxygenation index, mechanical ventilation time, hemodynamics, function of various organs and inflammation level. The aim of this study is to optimize the treatment of ARDS patients.
Eligibility Criteria
Inclusion Criteria: * Meeting the 2012 Berlin diagnostic criteria for acute respiratory distress syndrome; * Aged between 18-65 years (inclusive); * 95 times/min ≤ heart rate ≤120 times/min; * The patient needs to undergo endotracheal intubation mechanical ventilation after condition assessment; * Obtain the informed consent of the patient or his legal representative. Exclusion Criteria: * Bradycardia and second degree or more atrioventricular block; * Long-term use of beta-blockers; * Combined with emphysema, asthma and other β-blocker contraindicated diseases; * Cardiac insufficiency (NYHA grade Ⅲ or Ⅳ); * Pregnancy
Contact & Investigator
zhiming Jiang, doctor
STUDY DIRECTOR
Qianfo Mountain Hospital, Shandong Province
Frequently Asked Questions
Who can join the NCT06013319 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Acute Respiratory Distress Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06013319 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 178 participants.
Is NCT06013319 currently recruiting?
Yes, NCT06013319 is actively recruiting participants. Contact the research team at wangquanzhen1986@163.com for enrollment information.
Where is the NCT06013319 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT06013319 clinical trial?
NCT06013319 is sponsored by Zhiming Jiang. The principal investigator is zhiming Jiang, doctor at Qianfo Mountain Hospital, Shandong Province. The trial plans to enroll 178 participants.