Almitrine in COVID-19 Patients With ARDS Treated by HFNO

ARDS Clinical Trial

Official title:

Use of Almitrine in COVID-19 Patients With Acute Respiratory Distress Syndrome Treated by High-flow Nasal Canula Oxygen Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05216575
• Other study ID #: 22reamedcovid01
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: February 2022
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Clément SACCHERI, MD
• Phone: +33492035510
• Email: saccheri.c[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine the effects of Almitrine administration on oxygenation in COVID-19 patients with acute respiratory distress syndrome treated by high-flow nasal canula oxygen therapy as first-line ventilatory support.

Description:

From December 2019, the emergent coronavirus SARSCoV-2 is responsible for the worldwide pandemic of coronavirus disease (COVID-19). Although SARSCoV-2 infection is mainly responsible for mild respiratory symptoms, up to 70% of hospitalized patients with COVID-19-related pneumoniae may develop severe respiratory disease, progressing to acute respiratory distress syndrome (ARDS). These patients may experience severe but well-tolerated hypoxemia, so-called "happy hypoxemia" which may be related to blunted hypoxic vasoconstriction. Almitrine is a selective pulmonary vasoconstrictor that has been reported to improve the oxygenation in ARDS patients by increasing hypoxic pulmonary vasoconstriction. Some small case series reported that the use of Almitrine in mechanically ventilated COVID-19 patients with ARDS improved oxygenation. Given the "happy hypoxemia" phenomenon, it has been suggested to use high-flow nasal canula therapy (HFNO) as first-line ventilatory support in COVID-19 patients with ARDS, since the risk of aerosolization with HFNO was similar to that with standard oxygen therapy and lower to that with non-invasive ventilation. However, the effects of Almitrine in spontaneously breathing patients with ARDS has not been reported so far. Thus, the main goal of this study is to investigate the effects of Almitrine on oxygenation of COVID-19 patients with ARDS treated by HFNO as first-line ventilatory support. The second goal of this study is to determine the effects of Almitrine on respiratory mechanics and hymodynamics.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients treated by high-flow nasal canula oxygen

2. Positive COVID-19 real-time reverse transcriptase-polymerase chain reaction assay in nasal swabs

3. Persistent severe hypoxemia after awake prone positioning defined by one or more of the following criteria:

1. SpO2 < 96% with FiO2 > 80%

2. PaO2/FiO2 ratio < 100 with FiO2 > 80%

4. Patients treated by Almitrine

Exclusion Criteria:

1. Age <18 years old and pregnant women

2. Patients under legal protection

3. Patients with a do not intubate or do not resuscitate decision

4. Patients requiring immediate invasive mechanical ventilation

5. Contraindication to Almitrine

6. Poor echogenicity

Related Conditions & MeSH terms

• ARDS
• Hypoxemia
• Hypoxia

Intervention

Drug:
• Administration of Almitrine
Administration of Almitrine (intravenous bolus of 0.5 mg/kg over 30 minutes followed by a continuous perfusion of 16 mg/kg/min in responders)

Locations

Country	Name	City	State
France	CHU de NICE	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Almitrine-induced increase in Pa02/FiO2 ratio.	The PaO2/FiO2 ratio will be calculated before and after the bolus of Almitrine. Patients with increase in PaO2/FiO2 ratio > 20% will be considered as responders.	The 30-minute duration of Almitrine bolus
Secondary	Proportion of patients requiring intubation	To assess the proportion of patients who will require to be intubated during their ICU stay.	ICU stay
Secondary	Proportion of patients exhibiting right ventricular failure and/or right ventricular dilation and/or acute core pulmonale after administration of Almitrine.	To assess the proportion of patients who will experience right ventricular failure and/or right ventricular dilation and/or acute core pulmonale after administration of Almitrine.	The 30-minute duration of Almitrine bolus
Secondary	Clinical prediction of Almitrine effects	To test the ability of different respiratory variables and radiological patterns to predict the response to Almitrine in terms of oxygenation	The 30-minute duration of Almitrine bolus
Secondary	Radiological prediction of Almitrine effects	To test the ability of different radiological patterns to predict the response to Almitrine in terms of oxygenation	The 30-minute duration of Almitrine bolus