REMIMID-ICU: Remimazolam vs Midazolam for Deep Sedation in Hemodynamically Unstable, Mechanically Ventilated Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2027-09-30

Brief Summary

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This trial evaluates whether remimazolam provides superior sedation quality compared with midazolam in adults receiving invasive mechanical ventilation with ongoing vasopressor support. The primary outcome is the percentage of time within target sedation (RASS -3 to -5) without rescue sedative during the first 48 hours after randomization. Key secondary outcomes include vasopressor exposure (NEE AUC 0-48h), time to awakening, delirium incidence, ventilator-free days, and 28-day mortality.

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Detailed Description

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Conditions

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Critical Illness; Mechanical Ventilation; Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm A - Remimazolam

Continuous IV infusion; start 0.10 mg/kg/h and titrate every 15-30 minutes in 0.025-0.05 mg/kg/h steps to target RASS -3 to -5 (allowable range -2 to -5 for clinical safety). Maximum typical rate 0.20 mg/kg/h; temporary higher rates permitted per protocol for breakthrough agitation.

Group Type EXPERIMENTAL

Remimazolam Besylate

Intervention Type DRUG

Continuous IV infusion; start 0.10 mg/kg/h and titrate every 15-30 minutes in 0.025-0.05 mg/kg/h steps to target RASS -3 to -5 (allowable range -2 to -5 for clinical safety). Maximum typical rate 0.20 mg/kg/h; temporary higher rates permitted per protocol for breakthrough agitation.

Arm B - Midazolam

Continuous IV infusion; start 0.04 mg/kg/h and titrate every 15-30 minutes in 0.01-0.03 mg/kg/h steps to target RASS -3 to -5 (allowable range -2 to -5). Maximum typical rate 0.20 mg/kg/h per protocol.

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

Continuous IV infusion; start 0.04 mg/kg/h and titrate every 15-30 minutes in 0.01-0.03 mg/kg/h steps to target RASS -3 to -5 (allowable range -2 to -5). Maximum typical rate 0.20 mg/kg/h per protocol.

Interventions

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Remimazolam Besylate

Continuous IV infusion; start 0.10 mg/kg/h and titrate every 15-30 minutes in 0.025-0.05 mg/kg/h steps to target RASS -3 to -5 (allowable range -2 to -5 for clinical safety). Maximum typical rate 0.20 mg/kg/h; temporary higher rates permitted per protocol for breakthrough agitation.

Intervention Type DRUG

Midazolam

Continuous IV infusion; start 0.04 mg/kg/h and titrate every 15-30 minutes in 0.01-0.03 mg/kg/h steps to target RASS -3 to -5 (allowable range -2 to -5). Maximum typical rate 0.20 mg/kg/h per protocol.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years.
* Invasive mechanical ventilation at randomization; anticipated continuous sedation ≥24 hours.
* Hemodynamic instability requiring vasopressor support despite adequate resuscitation: NEE ≥0.10 μg/kg/min for ≥1 hour within 6 hours prior to randomization, or equivalent.
* At least one sign of hypoperfusion (e.g., lactate \>2 mmol/L, oliguria, mottled skin, or altered mentation) unless solely due to sedation.

Exclusion

• Known pregnancy; status epilepticus; severe hepatic failure (Child-Pugh C) or on ECMO; refractory hypoxemia requiring prone position at randomization; benzodiazepine hypersensitivity; need for continuous neuromuscular blockade \>24h at baseline; moribund not expected to survive 24h; investigator judgement.

Sexes Eligible: All Accepts Healthy Volunteers: No Ages: 18 Years and older

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No