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

NCT ID: NCT04611425

Last Updated: 2021-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-30
• Study Completion Date: 2021-10-22

Brief 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.

Detailed 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.

Conditions

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

Keywords

Remimazolam; Sedation; Shortage; Critical care; COVID-19

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Remimazolam

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)

Group Type: EXPERIMENTAL

Remimazolam

Intervention Type: DRUG

Patients will receive an infusion of Remimazolam for a maximum duration of 48 hours. The dose of Remimazolam will be adapted according to the ICU units protocol of analgesia-sedation management, based on validated scale (Richmond Assessment Sedation Scale). Owing to previous data gathered through a previous study in Japan, the initial dose of infusion will be within a 0.2-0.5 mg/min range. The dose of Remimazolam can be increased or decreased by 0.1mg/min when needed. The maximum dose of Remimazolam will be set at 1 mg/min.

Interventions

Remimazolam

Patients will receive an infusion of Remimazolam for a maximum duration of 48 hours. The dose of Remimazolam will be adapted according to the ICU units protocol of analgesia-sedation management, based on validated scale (Richmond Assessment Sedation Scale). Owing to previous data gathered through a previous study in Japan, the initial dose of infusion will be within a 0.2-0.5 mg/min range. The dose of Remimazolam can be increased or decreased by 0.1mg/min when needed. The maximum dose of Remimazolam will be set at 1 mg/min.

Intervention Type: DRUG

Other Intervention Names

Remimazolam (CNS 7056)

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Paion UK Ltd.

INDUSTRY

Sponsor Role: collaborator

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raphaël CINOTTI, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

CHU de Nantes

Nantes, , France

Countries

France

References

Grillot N, Vourc'h M, Hourmant Y, Bouras M, Rozec B, Rouhani A, Stoehr T, Jobert A, Roquilly A, Cinotti R. A phase 2 open-label pilot study of Remimazolam for sedation in critically ill patients. Anaesth Crit Care Pain Med. 2025 May;44(3):101510. doi: 10.1016/j.accpm.2025.101510. Epub 2025 Mar 31.

Reference Type: DERIVED

PMID: 40174701 (View on PubMed)

Other Identifiers

RC20_0319

Identifier Type: -

Identifier Source: org_study_id