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

NCT04611425 | Completed Phase 2 DMC

• 1 other identifier: RC20_0319
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• composite endpoint including a combination of cardio-vascular and sedation events, from baseline (before infusion) to 8 hours, after the beginning of Remimazolam infusion

  For Safety: Cardiovascular event: Hypotension will be defined as a Mean Arterial Pressure ≤65mmHg or an increase ≥50% of the dose of norepinephrine (if appropriate), sustained over one hour after the beginning of Remimazolam. For Efficacy: Sedation event: the investigator will check if Remimazolam provides an adequate level of sedation assessed with the Richmond Assessment Sedation Scale. The level of sedation will be set by the attending physician and is usually set at-1/0. The investigator will also monitor the need to use standard hypnotic drugs within this time frame as further medication (propofol, midazolam, dexmedetomidine) in case of Remimazolam inefficacy (Richmond Assessment Sedation Scale).

  8 hours after the beginning of infusion.

Secondary Outcomes (24)

• Adverse Events (all grades), related to Remimazolam.

  5 days

• Heart rate

  3 days

• Arterial pressure

  3 days

• Dose of norepinephrine

  3 days

• Electrocardiogram (ECG)

  3 days

Study Arms (1)

Remimazolam

EXPERIMENTAL

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)

Drug: Remimazolam

Interventions

Remimazolam 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.

Also known as: Remimazolam (CNS 7056)

Remimazolam

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients at least 18 years old
• Expected duration of general anaesthesia ≥ 24 hours

You may not qualify if:

• 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
• Patient under guardianship or trusteeship
• Patient under judicial protection
• Severe hepatic impairment defined as a Child-Pugh score \> 10.

Sponsors & Collaborators

• Nantes University Hospital: lead
• Paion UK Ltd.: collaborator

Study Sites (1)

CHU de Nantes

Nantes, France

Location

Related Publications (1)

• 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.

  PMID: 40174701 DERIVED

MeSH Terms

Conditions

COVID-19; Wounds and Injuries; Stroke; Sepsis; Shock

Interventions

remimazolam

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Raphaël CINOTTI, MD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-controlled

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: November 2, 2020
• Study Start: November 30, 2020
• Primary Completion: December 2, 2020
• Study Completion: October 22, 2021
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

FR (1)