Clinical trial
Effects of Esmolol on Oxygenation Index by Controlling Heart Rate in Patients With Acute Respiratory Distress Syndrome
Name
QFSKYLLTZH-2023-043
Description
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.
Trial arms
Trial start
2023-02-20
Estimated PCD
2026-04-30
Trial end
2026-10-30
Status
Recruiting
Phase
Early phase I
Treatment
Esmolol
The load dose of esmolol was first injected intravenously: 0.5mg/kg.min, for about 1 minute; then the maintenance dose was pumped intravenously: from 0.05mg/kg/min, and continued after 4 minutes if the efficacy was ideal; if the efficacy was poor, the load dose could be repeated and the maintenance dose increased by 0.05mg/kg/min. The maintenance dose should not exceed 0.3mg/kg/min.
Arms:
Esmolol group
Other names:
Esmolol hydrochloride injection
Size
178
Primary endpoint
Oxygenation index improved or not
From the start of the trial to 12 hours after administering the drug
Oxygenation index improved or not
From the start of the trial to 24 hours after administering the drug
Oxygenation index improved or not
From the start of the trial to 48 hours after administering the drug
Oxygenation index improved or not
From the start of the trial to 72 hours after administering the drug
Oxygenation index improved or not
From the start of the trial to 120 hours after administering the drug
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 178, 'type': 'ESTIMATED'}}
Updated at
2024-03-13
1 organization
1 product
1 indication
Organization
Zhiming JiangProduct
EsmololIndication
Acute Respiratory Distress Syndrome