REmimazolam Infusion in the Context of Hypnotic Shortage in the Critical Care Unit During the Pandemic of COVID-19: REHSCU Study

Nantes University Hospital (NUH)

Status and phase: Completed; Phase 2

Conditions: COVID-19; Shock; Stroke; Trauma; Acute Respiratory Failure; Sepsis

Treatments: Drug: Remimazolam

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04611425

RC20_0319

Details and patient eligibility

About

The worldwide COVID-19 pandemic has led to a dramatic increase in the number of patients hospitalized in intensive care units for an acute respiratory failure in all countries. This situation has quickly led to massive shortage in masks, mechanical ventilation machines and common medications such as hypnotics. All countries over the world are currently experiencing a major shortage in basic hypnotic medications (propofol, midazolam) in the intensive care as well as in the operating theatre. The Principal Investigator proposes to perform a pilot study assessing the benefit-risk ratio of Remimazolam (a novel benzodiazepine with a short half-life) in the critical care units of Nantes University Hospital during the COVID-19 pandemic.

Full description

The worldwide COVID-19 pandemic has led to a dramatic increase in the number of patients hospitalized in intensive care units for an acute respiratory failure in all countries. This situation has quickly led to massive shortage in masks, mechanical ventilation machines and common medications such as hypnotics. The reasons for such shortage are multiple: dramatic increase of the demand, production discontinuation because of shutdowns in multiple countries, and withholding of products by producing countries. All countries over the world are currently experiencing a major shortage in basic hypnotic medications (propofol, midazolam) in the intensive care as well as in the operating theatre. Remimazolam is a novel benzodiazepine with a short half-life that has been administered in patients undergoing major surgery, as well as in the intensive care unit. The Principal Investigator proposes to perform a pilot study assessing the benefit-risk ratio of Remimazolam in the critical care units of Nantes University Hospital during the COVID-19 pandemic.

Enrollment: 30 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients at least 18 years old
• Inclusion in the first 96 hours after ICU admission, after clinical stabilization according to the attending physician's discretion.
• Expected duration of general anaesthesia ≥ 24 hours

Exclusion criteria

• Patients more than 85 years-old
• Refusal to participate
• Severe patients with moribund state within the 24 hours after admission to the ICU
• Withdrawal of Life Sustaining Therapies within the 24 hours after admission to the ICU
• Any pregnant or breast-feeding patient,
• Patients with known anaphylactic reactions to benzodiazepines, flumazenil, or a medical condition such that these agents are contraindicated (according to local label)
• Patients with allergy/hypersensitivity to bovine lactose, dextran or any other excipient in the remimazolam product
• Presence of acute alcoholic or illicit drug intoxication or benzodiazepine intoxication
• Inclusion in another clinical (drug) trial
• Patient under guardianship or trusteeship
• Patient under judicial protection
• Severe hepatic impairment defined as a Child-Pugh score > 10.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Remimazolam

Experimental group

Description:

Patients will receive an infusion of Remimazolam for a maximum duration of 48 hours. The dose of Remimazolam will be adapted according to our ICU protocol of analgesia-sedation management, based on validated scale (Richmond Assessment Sedation Scale)

Treatment:

Drug: Remimazolam