Effect of Esmolol on Oxygenation Index in Patients With Acute Respiratory Distress Syndrome

NCT06013319 | Recruiting Phase 3

• 1 other identifier: QFSKYLLTZH-2023-043
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Distress Syndrome

Keywords

esmolol; ARDS; heart rate; oxygenation index

Outcome Measures

Primary Outcomes (5)

• Oxygenation index improved or not

  To evaluate the effect of Esmolol control on heart rate in patients with acute respiratory distress syndrome (ARDS) on oxygenation index.

  From the start of the trial to 12 hours after administering the drug

• Oxygenation index improved or not

  To evaluate the effect of Esmolol control on heart rate in patients with acute respiratory distress syndrome (ARDS) on oxygenation index.

  From the start of the trial to 24 hours after administering the drug

• Oxygenation index improved or not

  To evaluate the effect of Esmolol control on heart rate in patients with acute respiratory distress syndrome (ARDS) on oxygenation index.

  From the start of the trial to 48 hours after administering the drug

• Oxygenation index improved or not

  To evaluate the effect of Esmolol control on heart rate in patients with acute respiratory distress syndrome (ARDS) on oxygenation index.

  From the start of the trial to 72 hours after administering the drug

• Oxygenation index improved or not

  To evaluate the effect of Esmolol control on heart rate in patients with acute respiratory distress syndrome (ARDS) on oxygenation index.

  From the start of the trial to 120 hours after administering the drug

Secondary Outcomes (1)

• the difference of mechanical ventilation duration

  from the start of the trial to removal of the endotracheal tube and cessation of mechanical ventilation，up to 28 days

Study Arms (2)

Esmolol group

EXPERIMENTAL

Patients with ARDS who require mechanical ventilation after adequate disease assessment and whose heart rate continues to be ≥95 beats/min, but ≤120 beats/min within 24 hours after diagnosis, for at least 10 minutes without changing the dosage of catecholamine, were diagnosed as atrial fibrillation, atrial flutter or sinus tachycardia. The primary treatment is maintained while the esmolol load dose is administered and the maintenance dose is pumped continuously until the patient's heart rate is maintained between 80 and 94 beats per minute.

Drug: Esmolol

Control group

NO INTERVENTION

Patients with ARDS who need mechanical ventilation after adequate condition assessment and whose heart rate continues to be ≥95 beats /min but ≤120 beats /min after optimal hemodynamic treatment within 24 hours after diagnosis were randomly included in the control group. Routine mechanical ventilation, full sedation and analgesia, maintain RASS score 0-2 points; The target tidal volume is 6ml/kg, and the ventilator parameters should be adjusted in time according to the blood gas analysis. Hypotensive patients with sufficient blood volume should be pumped with pressor drugs. Timely sputum suction, airway management, eliminate fever, asthma, pain and other stimulation caused by the heart rate is too fast.

Interventions

Esmolol DRUG

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.

Also known as: Esmolol hydrochloride injection

Esmolol group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meeting the 2012 Berlin diagnostic criteria for acute respiratory distress syndrome;
• Aged between 18-65 years (inclusive);
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhiming Jiang: lead

Study Sites (1)

Department of Intensive Care Medicine

Jinan, Shandong, 250014, China

RECRUITING

Related Publications (4)

• Meyer NJ, Gattinoni L, Calfee CS. Acute respiratory distress syndrome. Lancet. 2021 Aug 14;398(10300):622-637. doi: 10.1016/S0140-6736(21)00439-6. Epub 2021 Jul 1.

  PMID: 34217425 BACKGROUND

• van der Jagt M, Miranda DR. Beta-blockers in intensive care medicine: potential benefit in acute brain injury and acute respiratory distress syndrome. Recent Pat Cardiovasc Drug Discov. 2012 Aug;7(2):141-51. doi: 10.2174/157489012801227274.

  PMID: 22642505 BACKGROUND

• Morelli A, Donati A, Ertmer C, Rehberg S, Kampmeier T, Orecchioni A, D'Egidio A, Cecchini V, Landoni G, Pietropaoli P, Westphal M, Venditti M, Mebazaa A, Singer M. Microvascular effects of heart rate control with esmolol in patients with septic shock: a pilot study. Crit Care Med. 2013 Sep;41(9):2162-8. doi: 10.1097/CCM.0b013e31828a678d.

  PMID: 23873274 BACKGROUND

• Levy B, Fritz C, Piona C, Duarte K, Morelli A, Guerci P, Kimmoun A, Girerd N. Hemodynamic and anti-inflammatory effects of early esmolol use in hyperkinetic septic shock: a pilot study. Crit Care. 2021 Jan 7;25(1):21. doi: 10.1186/s13054-020-03445-w.

  PMID: 33413583 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

esmolol

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• zhiming Jiang, doctor

  Qianfo Mountain Hospital, Shandong Province

  STUDY DIRECTOR

Central Study Contacts

Quanzhen Wang, doctor

CONTACT

15562570205; wangquanzhen1986@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 28, 2023
• Study Start: February 20, 2023
• Primary Completion: April 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)