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

• Status: Completed
• Trial end date: 2021-10-22
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nantes University Hospital
• Collaborator: Paion UK Ltd.

Criteria

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.